Identity
- Trade Name
- Cook FDA UDI
- Generic Name
- Prostate brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Cook Brachytherapy Needle FDA UDI
- Model / Reference
- G17617 FDA UDI
- Description
- Cook Brachytherapy Needle FDA UDI
Identifiers
- Catalog Number
- CBN-018020 FDA UDI
- Primary DI / UDI-DI
- 00827002176171 FDA UDI
- FDA Product Code
- IWJ FDA UDI
- GMDN Term
- Prostate brachytherapy system applicator, remote-afterloading FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.5650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Prostate brachytherapy system applicator, remote-afterloading
Cook by Cook Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI 0f075c29-4295-4b13-b73d-1cb3ab97814e 36 fields · synced Jun 8, 2026