Identity
- Trade Name
- Bioseal Inc. FDA UDI
- Generic Name
- Suture retention device FDA UDI
- Device Name
- Button Polyester 9/16" - 14mm FDA UDI
- Model / Reference
- 19973/20 FDA UDI
- Description
- Button Polyester 9/16" - 14mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00630094997322 FDA UDI
- FDA Product Code
- KGS FDA UDI
- GMDN Term
- Suture retention device FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4930 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Suture retention device
Bioseal Inc. by Bioseal — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suture retention device.
- FlowStasis Single-Pack — Inari Medical, Inc. · Class I
- ATLAS Suture Delivery System — Applied Medical Technology, Inc. · Class II
- ETHICON — Ethicon Inc. · Class II
- ETHICON — Ethicon Inc. · Class II
- ETHICON — Johnson & Johnson International Inc. · Class II
- ATLAS Suture Delivery System — Applied Medical Technology, Inc. · Class II
- Perchik Button™ — Merit Medical Systems, Inc. · Class I
- FlowStasis — Inari Medical, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bioseal
Sources (1)
- FDA UDI 1993b6e1-e5cd-43d0-aa11-38dd6d79a1ad 33 fields · synced May 30, 2026