Identity
- Trade Name
- Dilation Syringe EUDAMEDCook FDA UDI
- Generic Name
- Catheter/overtube balloon inflator, single-use FDA UDI
- Device Name
- Dilation Syringe EUDAMEDFDA UDI
- Model / Reference
- DS-60CC-S EUDAMEDG27112 FDA UDI
- Description
- Dilation Syringe FDA UDI
Identifiers
- Catalog Number
- DS-60CC-S FDA UDI
- Primary DI / UDI-DI
- 00827002271128 EUDAMEDFDA UDI
- Basic UDI-DI
- 0827002WCM00000000030MH EUDAMED
- 510(k) Number
- K936168 FDA UDI
- FDA Product Code
- KNT FDA UDI
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Catheter/overtube balloon inflator, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Gastro-urological guidewire, single-use
Dilation Syringe by Wilson-Cook Medical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Gastro-urological guidewire, single-use.
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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 | 0827002WCM00000000030MH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Wilson-Cook Medical, Inc.
- EUDAMED SRN
- US-MF-000002658
- Authorised Representative
- COOK MEDICAL EUROPE LIMITED IE-AR-000000907
Sources (3)
- EUDAMED 33022f6a-730a-4f78-9f94-c58aee26715a 61 fields · synced Oct 8, 2026
- FDA UDI b5c185b1-6e7b-439c-9cad-0509c4c102c6 37 fields · synced May 30, 2026
- EUDAMED bb011681-1750-4b98-8cbc-0817b4ce5c65 61 fields · synced Jun 19, 2026