Identity
- Trade Name
- SMS Surgical gown, Standard EUDAMEDExact Medical Manufacturing, Inc. FDA UDI
- Generic Name
- Surgical gown, single-use FDA UDI
- Device Name
- SMS Surgical gown, Standard EUDAMEDGown , Standard with 2 Towels , L , SMS FDA UDI
- Model / Reference
- EU000150 EUDAMEDFDA UDI
- Description
- Gown , Standard with 2 Towels , L , SMS FDA UDI
Identifiers
- Catalog Number
- EU000150 FDA UDI
- Primary DI / UDI-DI
- 06975085700241 EUDAMEDFDA UDI
- Basic UDI-DI
- 697508570SG01MP EUDAMED
- FDA Product Code
- FYA FDA UDI
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
- GMDN Term
- Surgical gown, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
SMS Surgical gown, Standard by Exact Medical Manufacturing, Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697508570SG01MP | Class I | Active |
| 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
- Exact Medical Manufacturing, Inc
- EUDAMED SRN
- CN-MF-000001406
- Authorised Representative
- Exact Medical Manufacturing B.V. NL-AR-000000452
Sources (2)
- EUDAMED ef8e3da0-8ab5-42c0-83c6-97965001a471 61 fields · synced Oct 6, 2026
- FDA UDI fe28ffad-db82-4954-9744-7f0903de4a00 34 fields · synced May 30, 2026