Identity
- Trade Name
- Plasma-Cel Large Single Pouch FDA UDI
- Generic Name
- Surgical instrument guard, single-use FDA UDI
- Device Name
- Plasma-Cel Large Single Pouch - 4 in. x 7 in. - 25 Large Single Pouches FDA UDI
- Model / Reference
- PC6210 FDA UDI
- Description
- Plasma-Cel Large Single Pouch - 4 in. x 7 in. - 25 Large Single Pouches FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843356101522 FDA UDI
- FDA Product Code
- LRP FDA UDI
- GMDN Term
- Surgical instrument guard, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical instrument guard, single-use
Plasma-Cel Large Single Pouch by Cygnus Medical L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument guard, single-use.
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- Simpulse — Davol Inc. · Class II
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- Steri-Pocket — Hanes Companies, Inc. · Class I
- MSI Precision Specialty Instruments — Med Saver, 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
- Cygnus Medical L.l.c.
Sources (1)
- FDA UDI 4508fe2a-c81b-487b-8050-165dd88aeb52 33 fields · synced Jun 1, 2026