Identity
- Trade Name
- MEDICOM SAFEBASICS FDA UDI
- Generic Name
- Professional examination gown, single-use FDA UDI
- Device Name
- MEDICOM SAFEBASICS ISOLATION GOWN X-Large FDA UDI
- Model / Reference
- 8024 FDA UDI
- Description
- MEDICOM SAFEBASICS ISOLATION GOWN X-Large FDA UDI
Identifiers
- Catalog Number
- 8024 FDA UDI
- Primary DI / UDI-DI
- 20686864049597 FDA UDI
- FDA Product Code
- OEA FDA UDI
- GMDN Term
- Professional examination gown, 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: Professional examination gown, single-use
Medicom Safebasics by AMD Medicom Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Professional examination gown, single-use.
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Dealmed — DEALMED MEDICAL SUPPLIES LLC · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- CMATT — CASCO MANUFACTURING SOLUTIONS, INC. · Class I
- Essential Cares — Essential Cares Supplies, Inc. · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- VIVIT Supply — Vivit Supply 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
- AMD Medicom Inc
Sources (1)
- FDA UDI a30b9176-1d43-4f1a-bbc2-d1cc9c53626e 37 fields · synced Jun 6, 2026