Identity
- Trade Name
- Marpac Inc FDA UDI
- Generic Name
- Dressing-fixation skin adhesive tape, non-silicone FDA UDI
- Device Name
- Adhesive precut cloth tape strip, 1"x8", paper backed, bag contains 100ea FDA UDI
- Model / Reference
- 389B FDA UDI
- Description
- Adhesive precut cloth tape strip, 1"x8", paper backed, bag contains 100ea FDA UDI
Identifiers
- Catalog Number
- 389B FDA UDI
- Primary DI / UDI-DI
- 20653658003899 FDA UDI
- FDA Product Code
- KGX FDA UDI
- GMDN Term
- Dressing-fixation skin adhesive tape, non-silicone FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5240 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: Dressing-fixation skin adhesive tape, non-silicone
Marpac Inc by Marpac, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dressing-fixation skin adhesive tape, non-silicone.
- ARROW — TELEFLEX INCORPORATED · Class I
- McDavid — Doctor Shock Inc · Class I
- Cramer Athletic Tape — CRAMER PRODUCTS, INC. · Class I
- ANCORIS* — Avanos Medical, Inc. · Class I
- 16PW - Class A Burn Relief — Certified Safety Manufacturing, Inc. · Class I
- 16PW - Class A Blue Metal Detectable - Poly White — Certified Safety Manufacturing, Inc. · U
- EMT - Class B Trauma - Bag — Certified Safety Manufacturing, Inc. · Class I
- Mefix® — 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
- Marpac, Inc.
Sources (1)
- FDA UDI 253b0bc3-a58f-451e-9572-d5a577257cd7 35 fields · synced May 30, 2026