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Sterilization box for segmented cervix applicator set GM11004540
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Sterilization box for segmented cervix applicator set GM11004540 FDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- GM11010310 FDA UDI
Identifiers
- Catalog Number
- GM11010310 FDA UDI
- Primary DI / UDI-DI
- 00816389025301 FDA UDI
- 510(k) Number
- K160021 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- Vaginal 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
No
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: Vaginal brachytherapy system applicator, remote-afterloading
Sterilization box for segmented cervix applicator set GM11004540 by Varian Medical Systems Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Vaginal brachytherapy system applicator, remote-afterloading.
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- Vaginal CT/MR Applicator — Nucletron B.V. · Class II
- Kobold® Vaginal Cylinder Applicator Set (E) — KOBOLD, LLC · Class II
- Wall holder for source and transfer guide tubes — Varian Medical Systems, Inc · Class II
- Vaginal Applicator — Nucletron B.V. · Class II
Cleared under the same submission
K160021 also covers:
- Needle box to store needles during reprocessing — Varian Medical Systems Deutschland GmbH
- Small component box to store small componenets during reprocessing — Varian Medical Systems Deutschland GmbH
- Sterilization box for Segmented Cylinder Applicator Set G11004150 — Varian Medical Systems Deutschland GmbH
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
- Varian Medical Systems Deutschland GmbH
Sources (1)
- FDA UDI b225155f-3a4c-48b3-aba2-fef6d9c2907e 34 fields · synced Jun 6, 2026