Identity
- Trade Name
- KleenSpec EUDAMEDWelch Allyn, Inc. FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- BOX 590 DISP SHEATHS FDA UDI
- Model / Reference
- 901017 EUDAMEDFDA UDI59010 EUDAMED
- Description
- BOX 590 DISP SHEATHS FDA UDI
Identifiers
- Catalog Number
- 411707 FDA UDI
- Primary DI / UDI-DI
- 00732094214246 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732094GMN901017EX EUDAMED
- Unit of Use DI
- 00732094239669 EUDAMED
- FDA Product Code
- HIB FDA UDI
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
KleenSpec by Welch Allyn, 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 | 0732094GMN901017EX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Welch Allyn, Inc.
- EUDAMED SRN
- US-MF-000013394
- Authorised Representative
- Welch Allyn Limited IE-AR-000000768
Sources (2)
- EUDAMED 11ab8570-3ecb-4b1a-9b53-93eb46c63ad1 61 fields · synced Jul 17, 2026
- FDA UDI 6c08e66f-2cd2-4669-abd1-20dfd4ac235b 35 fields · synced May 30, 2026