Identity
- Trade Name
- Dermacea FDA UDI
- Generic Name
- Lumbar interspinous decompression instrument set, reusable FDA UDI
- Device Name
- Gauze Roll,3 Ply FDA UDI
- Model / Reference
- 441123 FDA UDI
- Description
- Gauze Roll,3 Ply FDA UDI
Identifiers
- Catalog Number
- 441123 FDA UDI
- Primary DI / UDI-DI
- 10884527020966 FDA UDI
- FDA Product Code
- NAB FDA UDI
- GMDN Term
- Lumbar interspinous decompression instrument set, reusable 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
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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 3 Inch FDA UDI
Category: Lumbar interspinous decompression instrument set, reusable
Dermacea by Cardinalhealth — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lumbar interspinous decompression instrument set, reusable.
- K2M General Instruments — K2M, INC. · Class I
- Zavation — ZAVATION · Class II
- K2M General Instruments — K2M, INC. · Class I
- Axle Interspinous Fusion System — Xtant Medical Holdings, Inc. · Class I
- K2M General Instruments — K2M, INC. · Class I
- K2M General Instruments — K2M, INC. · Class I
- K2M General Instruments — K2M, INC. · Class I
- Axle Interspinous Fusion System — Xtant Medical Holdings, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cardinalhealth
Sources (1)
- FDA UDI 2234298d-fd7a-4a2c-b80a-ec609dda8cd3 37 fields · synced May 30, 2026