Identity
- Trade Name
- GAUZE PACKER & LIGATURE DIRECTOR D/E 2.0mm FDA UDI
- Generic Name
- Gauze packer FDA UDI
- Model / Reference
- 20-1158 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D9282011580 FDA UDI
- FDA Product Code
- EKG FDA UDI
- GMDN Term
- Gauze packer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Moist Heat or Steam Sterilization FDA UDI
Category: Gauze packer
GAUZE PACKER & LIGATURE DIRECTOR D/E 2.0mm by W.H. Holden, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gauze packer.
- Bioseal Inc. — BIOSEAL · Class I
- ZOLL-DENTAL — Zoll-Dental · Class I
- AESCULAP — AESCULAP, INC. · Class I
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- ZOLL-DENTAL — Zoll-Dental · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- W.H. Holden, Inc.
Sources (1)
- FDA UDI c7e97a16-c1ea-4b6a-9071-83bcb31917d4 32 fields · synced May 30, 2026