Identity
- Trade Name
- Sorbalgon 1" x 12" Rope P5 C10 FDA UDI
- Generic Name
- Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial FDA UDI
- Device Name
- Sorbalgon 1" x 12" Rope P5 C10 FDA UDI
- Model / Reference
- 49220001 FDA UDI
- Description
- Sorbalgon 1" x 12" Rope P5 C10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04052199545950 FDA UDI
- FDA Product Code
- NAC FDA UDI
- GMDN Term
- Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4018 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Sorbalgon 1" x 12" Rope P5 C10 by Hartmann Usa Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial.
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- DUODERM — CONVATEC, PURCHASING DEPARTMENT · Class I
- Eclypse Adherent — BRIGHTWAKE LIMITED · Class I
- Cutimed® Sorbion® — BSN 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
- Hartmann Usa Inc.
Sources (1)
- FDA UDI aaa01cf3-c85d-4a1f-a3cf-d93a0538cb26 33 fields · synced May 30, 2026