7247
Ref 7247
7247 is a Class I device made by Stryker Leibinger, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-07613252083757), cleared under FDA 510(k) K981374 on 2 Jul 1998 and listed in FDA GUDID since 24 Aug 2016 (UDI-DI 07613252083757), active as of 7 Nov 2026.
Active
CE MDD 510(k)
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-07613252083757 07613252083757 | Date5 Nov 2026 | StatusActive |
| United States | GUDID listing GUDID | Number07613252083757 | Date24 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE GUDID | NumberK981374 | Date2 Jul 1998 | StatusActive |
Official records
- EUDAMED public site B-07613252083757
- AccessGUDID record 07613252083757
- FDA 510(k) database K981374
Across registries
- EUDAMED Basic UDI-DI B-07613252083757 registered 5 Nov 2026 Active
- FDA 510(k) K981374 decided 2 Jul 1998 Active
- FDA GUDID UDI-DI 07613252083757 listed 24 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K981374
- Listed FDA GUDID 07613252083757
- Registered EUDAMED B-07613252083757
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic name
- Intranasal splint, non-biodegradable
- Model / Ref / Catalog
- 7247
- Primary DI / UDI-DI
- 07613252083757
- Basic UDI-DI
- B-07613252083757
- 510(k) Number
- FDA product code
- LYA
- EMDN code
- P900403 Non-resorbable filling and reconstruction devices
- GMDN term
- Intranasal splint, non-biodegradable
- Device class
- Class I
- Regulation number
- 874.4780
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 32.0 MillimeterWidth — 25.0 Millimeter
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