Identity
- Trade Name
- Ring Applicator FDA UDI
- Generic Name
- Cervical/intrauterine brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Rectal Retractor, 90deg FDA UDI
- Model / Reference
- 084338P01-03 FDA UDI
- Description
- Rectal Retractor, 90deg FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717213042964 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- Cervical/intrauterine brachytherapy system applicator, remote-afterloading FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Cervical/intrauterine brachytherapy system applicator, remote-afterloading
Ring Applicator by Nucletron B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cervical/intrauterine brachytherapy system applicator, remote-afterloading.
- Best Medical International — Best Medical International, Inc. · Class I
- Best Medical International — Best Medical International, Inc. · Class I
- Best Medical International — Best Medical International, Inc. · Class I
- Ring Applicator Set 90 degree — Varian Medical Systems Deutschland GmbH · Class II
- Best Medical International — Best Medical International, Inc. · Class I
- Best Medical International — Best Medical International, Inc. · Class I
- Best Medical International — Best Medical International, Inc. · Class I
- Intrauterine tandems, right and left, 320 mm length, angle 20 degrees x 70 mm — Varian Medical Systems Deutschland GmbH · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Nucletron B.V.
Sources (1)
- FDA UDI bb2c3d9f-3b16-48ae-9311-f1e7a88481c4 34 fields · synced May 31, 2026