Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Surgical dressing/drape kit, single-use FDA UDI
- Device Name
- DRAPE,INCISE,24"X14",INVISISHIELD FDA UDI
- Model / Reference
- DYNJSD1040 FDA UDI
- Description
- DRAPE,INCISE,24"X14",INVISISHIELD FDA UDI
Identifiers
- Catalog Number
- DYNJSD1040 FDA UDI
- Primary DI / UDI-DI
- 10080196739295 FDA UDI
- FDA Product Code
- PUI FDA UDI
- GMDN Term
- Surgical dressing/drape kit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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
Yes
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
No
FDA UDI
Category: Surgical dressing/drape kit, single-use
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical dressing/drape kit, single-use.
- PureLife+ 2-Ply Dental Bibs — PURELIFE, LLC · Class I
- HYGITECH — HYGITECH · Class I
- ASK-1 Aspiration Starter Kit — RANFAC CORP. · Class II
- HYGITECH — HYGITECH · Class II
- HYGITECH — HYGITECH · Class I
- HYGITECH — HYGITECH · Class I
- PureLife+ 2-Ply Dental Bibs — PURELIFE, LLC · Class I
- AD Surgical — APPLIED DENTAL, INC. · Class II
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medline Industries, Inc.
Sources (1)
- FDA UDI 00c96070-28a1-4448-8e2e-405af9a32906 35 fields · synced Jun 8, 2026