Identity
- Trade Name
- Spunlance Surgical Gown, Standard EUDAMEDExact Medical Manufacturing, Inc. FDA UDI
- Generic Name
- Surgical gown, single-use FDA UDI
- Device Name
- Spunlance Surgical Gown, Standard EUDAMEDXL, Non-Reinforced Sontara Gown, Spunlace FDA UDI
- Model / Reference
- 2110 EUDAMED2110-VET FDA UDI
- Description
- XL, Non-Reinforced Sontara Gown, Spunlace FDA UDI
Identifiers
- Catalog Number
- 2110-VET FDA UDI
- Primary DI / UDI-DI
- 06975085708513 EUDAMEDFDA UDI
- Basic UDI-DI
- 697508570SG04MV EUDAMED
- 510(k) Number
- K111535 FDA UDI
- 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Spunlance 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 | 697508570SG04MV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Exact Medical Manufacturing, Inc
- EUDAMED SRN
- CN-MF-000001406
- Authorised Representative
- Exact Medical Manufacturing B.V. NL-AR-000000452
Sources (2)
- EUDAMED d9de4c9e-5e37-41f0-84ee-57d380e62383 61 fields · synced Jul 24, 2026
- FDA UDI aa116604-b5d2-4f4b-b347-f12ee55fb912 35 fields · synced May 30, 2026