Identity
- Trade Name
- Elite Self-Adherent Wrap FDA UDI
- Generic Name
- Non-adhesive device retention bandage FDA UDI
- Device Name
- Self-Adherent Wrap - 4x5yds / Elite First Aid Part Number: 507 FDA UDI
- Model / Reference
- ELITE-17104 FDA UDI
- Description
- Self-Adherent Wrap - 4x5yds / Elite First Aid Part Number: 507 FDA UDI
Identifiers
- Catalog Number
- Not Applicable FDA UDI
- Primary DI / UDI-DI
- 00816703023068 FDA UDI
- FDA Product Code
- KGX FDA UDI
- GMDN Term
- Non-adhesive device retention bandage 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: Non-adhesive device retention bandage
Elite Self-Adherent Wrap by Medsource International Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-adhesive device retention bandage.
- Healqu — HEALQU LLC. · Class I
- ASP MEDICAL — Asp Global, LLC · Class I
- Tetra-Net — TETRA MEDICAL SUPPLY CORP. · Class I
- CurPro Undercast Padding, 100% Polyester, 2" x 4 yd — Dynarex Corp. · Class I
- AMD-RITMED — AMD Medicom Inc · Class I
- Co-Ease — HEMASOURCE · Class I
- Healqu — HEALQU LLC. · Class I
- CotZee — HEMASOURCE · 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
- Medsource International Llc
Sources (1)
- FDA UDI 97ed925f-08dc-46bc-9a47-23dee1fb09ac 34 fields · synced Jun 1, 2026