Identity
- Trade Name
- ACE FDA UDI
- Generic Name
- Gauze packer FDA UDI
- Device Name
- PACKER GAUZE HEAVY D/E 7-3/4" 19.5CM FDA UDI
- Model / Reference
- 0800172 FDA UDI
- Description
- PACKER GAUZE HEAVY D/E 7-3/4" 19.5CM FDA UDI
Identifiers
- Catalog Number
- 0800172 FDA UDI
- Primary DI / UDI-DI
- 00614950022304 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Gauze packer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 7.75 Inch FDA UDI
Category: Gauze packer
Ace by Ace Surgical Supply Co., Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
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- 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 |
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Manufacturer
- Manufacturer
- Ace Surgical Supply Co., Inc.
Sources (1)
- FDA UDI 9b6be709-435d-4120-9b17-bd7cf020215c 37 fields · synced May 30, 2026