Identity
- Trade Name
- FixoLong FDA UDI
- Generic Name
- Adhesive bandage FDA UDI
- Device Name
- FixoLong Fixation system for Catheter and Filter FDA UDI
- Model / Reference
- 001163-60 FDA UDI
- Description
- FixoLong Fixation system for Catheter and Filter FDA UDI
Identifiers
- Catalog Number
- 001163-60 FDA UDI
- Primary DI / UDI-DI
- 04048223118696 FDA UDI
- FDA Product Code
- KGZ FDA UDI
- GMDN Term
- Adhesive bandage FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 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
Dimensions & Sizes
- Size
- Pore Size — 0.2 Micrometer FDA UDI
Category: Adhesive bandage
FixoLong by Pajunk GmbH Medizintechnologie — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Adhesive bandage.
- Telfa — Cardinalhealth · Class I
- Silverlon Antimicrobial Wound Dressing — ARGENTUM MEDICAL, LLC · U
- CURAD — MEDLINE INDUSTRIES, INC. · Class I
- Protect U Guard Flexible Fabric Adhesive Bandages — PROTECT U GUARD, LLC · Class I
- Compeed Twin Pack Med 2ct — HRA PHARMA AMERICA, INC. · Class I
- ColorFit Adhesive Fabric Bandages, Dark Brown, 3/4" x 3" — Dynarex Corp. · Class I
- 16PW - Class A Burn Relief — Certified Safety Manufacturing, Inc. · Class I
- Mepilex® Border Post-Op — Mölnlycke Health Care AB · 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
- Pajunk GmbH Medizintechnologie
Sources (1)
- FDA UDI ef5e9160-1477-45f8-93ac-80e7206a59c6 37 fields · synced May 29, 2026