OptiSeal™ 1000093-002
OptiSeal™ 1000093-002 is a Class II device made by Greatbatch Ltd, listed in FDA GUDID since 15 Aug 2019 (UDI-DI 00821329000720), registry data as of 9 Nov 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00821329000720 | Date15 Aug 2019 | StatusListed |
Official records
- AccessGUDID record 00821329000720
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- OptiSeal™
- Generic name
- Vascular catheter introduction set, nonimplantable
- Model / Ref / Catalog
- 1000093-002
- Primary DI / UDI-DI
- 00821329000720
- FDA product code
- DYB
- GMDN term
- Vascular catheter introduction set, nonimplantable
- Device class
- Class II
- Regulation number
- 870.1340
- GUDID distribution status
- In Commercial Distribution
- Size
- Catheter Gauge — 7 French
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