← Back to catalogue
Gauze / Sponge, Nonresorbable For External Use
FDA UDIClass I (US FDA UDI)
by Jhk, Inc.
Identity
- Trade Name
- GAUZE / SPONGE, NONRESORBABLE FOR EXTERNAL USE FDA UDI
- Generic Name
- Woven gauze roll/sheet FDA UDI
- Model / Reference
- 0551, 0552, 0553, 0572, 0573, 0802, 0803, 0804, 0822, 0832, 0842, 0825, FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009716148 FDA UDI
- FDA Product Code
- NAB FDA UDI
- GMDN Term
- Woven gauze roll/sheet FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4014 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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Woven gauze roll/sheet
Gauze / Sponge, Nonresorbable For External Use by Jhk, Inc. — Class I — 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
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
- Jhk, Inc.
Sources (1)
- FDA UDI c091c836-8aae-45f2-ae4f-51025fb6a5e6 32 fields · synced May 30, 2026