Identity
- Trade Name
- Bioseal Inc. FDA UDI
- Generic Name
- Umbilical cord tape FDA UDI
- Device Name
- Umbilical Tape FDA UDI
- Model / Reference
- 6812/100 FDA UDI
- Description
- Umbilical Tape FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00630094068121 FDA UDI
- FDA Product Code
- FOD FDA UDI
- GMDN Term
- Umbilical cord tape FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5950 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Umbilical cord tape
Bioseal Inc. by Bioseal — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Umbilical cord tape.
- STRADIS HEALTHCARE — STRADIS MEDICAL, LLC · Class I
- Dermapac, Inc. — Dermapac Inc. · Class I
- Dermapac, Inc. — Dermapac Inc. · Class I
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- Manus Medical, LLC — Manus Medical, LLC · Class II
- Umbilical Tape — RIVERPOINT MEDICAL LLC · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- ETHICON — Ethicon 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
- Bioseal
Sources (1)
- FDA UDI 2f15c578-adbd-4a3c-a80a-8cae0061769b 33 fields · synced Jun 6, 2026