Identity
- Trade Name
- Dukal FDA UDI
- Generic Name
- Scrub suit, single-use FDA UDI
- Device Name
- Scrub Shirt XL FDA UDI
- Model / Reference
- 375XL FDA UDI
- Description
- Scrub Shirt XL FDA UDI
Identifiers
- Catalog Number
- 375XL FDA UDI
- Primary DI / UDI-DI
- 10665973003259 FDA UDI
- FDA Product Code
- LYU FDA UDI
- GMDN Term
- Scrub suit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4040 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
Yes
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: Scrub suit, single-use
Dukal by Dukal LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Scrub suit, single-use.
- SURGIPLUS — KENPAX INTERNATIONAL LIMITED · Class I
- Tronex International, Inc. — TRONEX INTERNATIONAL, INC. · Class I
- Regard™ — RESOURCE OPTIMIZATION & INNOVATION, L.L.C. · Class I
- Regard™ — RESOURCE OPTIMIZATION & INNOVATION, L.L.C. · Class I
- ASP MEDICAL — Asp Global, LLC · Class I
- Disposable Scrub Pants — Dynarex Corp. · Class I
- Disposable Scrub Shirt, V-Neck — Dynarex Corp. · Class I
- ASP MEDICAL — Asp Global, LLC · 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
- Dukal LLC
Sources (1)
- FDA UDI ca88b309-94a9-426d-9e29-73c7f13943ce 35 fields · synced Jun 8, 2026