Identity
- Trade Name
- Cook FDA UDI
- Generic Name
- Fascial tissue dilator, single-use FDA UDI
- Device Name
- Dilator [Long Taper] EUDAMEDDilator FDA UDI
- Model / Reference
- JCD5.0-38-20 EUDAMEDG00983 FDA UDI
- Description
- Dilator FDA UDI
Identifiers
- Catalog Number
- JCD5.0-38-20 FDA UDI
- Primary DI / UDI-DI
- 00827002009837 EUDAMEDFDA UDI
- Basic UDI-DI
- 0827002CINC014-031_AHD EUDAMED
- FDA Product Code
- FGE FDA UDI
- EMDN Code
- C9002 VASCULAR AND FASCIAL DILATORS EUDAMED
- GMDN Term
- Fascial tissue dilator, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5010 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Category: Fascial tissue dilator, single-use
Cook by Cook Incorporated — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Fascial tissue dilator, single-use.
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- Vessel Dilator — Argon Medical Devices, Inc. · Class II
- Evolution — COOK VANDERGRIFT INC. · Class II
- VisiSheath Dilator Sheath — Spectranetics Corporation · Class III
- Byrd — COOK VANDERGRIFT INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cook Incorporated
Sources (2)
- FDA UDI 3fb8946a-ac91-496f-a7a7-f0542161b48a 36 fields · synced Jul 17, 2026
- EUDAMED c1395a23-6450-4144-b1c3-650a3e5a10cb 61 fields · synced Jul 17, 2026