Identity
- Trade Name
- CALICO FDA UDI
- Generic Name
- Woven gauze roll/sheet FDA UDI
- Device Name
- Antimicrobial Gauze FDA UDI
- Model / Reference
- GZ001 FDA UDI
- Description
- Antimicrobial Gauze FDA UDI
Identifiers
- Catalog Number
- GZ001 FDA UDI
- Primary DI / UDI-DI
- 00850044458684 FDA UDI
- 510(k) Number
- K181315 FDA UDI
- FDA Product Code
- EFQ FDA UDI
- GMDN Term
- Woven gauze roll/sheet FDA UDI
Classification
- Device Class
- U 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Woven gauze roll/sheet
Calico by Calico Medical Group LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Woven gauze roll/sheet.
- CVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · Class I
- Derma Sciences — Derma Sciences Canada, Inc · Class I
- Dukal — Dukal LLC · Class I
- Tronex International, Inc. — TRONEX INTERNATIONAL, INC. · Class I
- FlannelPlus™ — Derma Sciences Canada, Inc · Class I
- MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class I
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
- MedSource ABD Pads — MEDSOURCE INTERNATIONAL LLC · Class I
Cleared under the same submission
K181315 also covers:
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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Calico Medical Group LLC
Sources (1)
- FDA UDI c0ca698f-b594-4bb5-b476-d661d8360fb7 35 fields · synced May 30, 2026