Rusch Latex Gold Foley Catheter
Teleflex Medical Sdn. Bhd. · Gastroenterology, Urology
Open FDA's page for this record- Third party flag
- N
- City
- Kamunting
- Advisory committee description
- Gastroenterology, Urology
- Address 1
- Lot Pt. 2577,
- Address 2
- Jalan Perusahaan 4
- Statement or summary
- Summary
- Product code
- EZL
- Zip code
- 34000
- Applicant
- Teleflex Medical Sdn. Bhd.
- Decision date
- 2026-08-05
- Decision code
- SESE
- Country code
- MY
- Device name
- Rusch Latex Gold Foley Catheter
- Advisory committee
- GU
- Contact
- Yuvaanesswary Nallappan
- K number
- K262056
- Date received
- 2026-06-18
- Review advisory committee
- GU
- Postal code
- 34000
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Catheter, Retention Type, Balloon
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.5130
- Device class
- 2
- Registration number
- 3022516937, 3004070478, 1417592, 8030107, 3005609751, 3012050423, 9612030, 8022978, 3015142802, 1314417, 3010220595, 3006787036, 3004111573, 3005669815, 1820334, 3031190571, 3005515211, 1058397, 3011252788, 3009086335, 3005012805, 3030446844, 3014650073, 3005483737, 1018233, 3011383638, 3005941719, 3020978007, 9616088, 8041005, 3008496528, 3011137372, 1649518, 3010314836, 3016618143, 3014766734, 3013369910, 3013002100, 2320762, 1061124 +80 more
- FEI number
- 3022516937, 3004070478, 1417592, 7682, 3005609751, 3012050423, 3015142802, 1314417, 3010220595, 3006787036, 3004111573, 3005669815, 1820334, 3031190571, 3005515211, 3009271244, 3016261803, 3002806934, 3011252788, 3009086335, 3005012805, 1000112877, 1000160458, 3001236277, 3030446844, 3014650073, 1000512168, 3005483737, 1018233, 1000521377, 3011383638, 3000215273, 3020978007, 3008496528, 3010314836, 3016618143, 3014766734, 3013369910, 3013002100, 3027301746 +80 more