Identity
- Trade Name
- Mini-colpostats, pair FDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- GM11000900 FDA UDI
Identifiers
- Catalog Number
- GM11000900 FDA UDI
- Primary DI / UDI-DI
- 00816389021785 FDA UDI
- 510(k) Number
- K120731 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
Mini-colpostats, pair by Varian Medical Systems Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vaginal brachytherapy system applicator, remote-afterloading.
- Source guide tube with locking mechanism, third party applicator — Varian Medical Systems, Inc · Class II
- Vaginal Applicator — Nucletron B.V. · Class II
- Miami Vaginal Applicator — Nucletron B.V. · Class II
- Vaginal CT/MR Applicator — Nucletron B.V. · Class II
- 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
K120731 also covers:
- Allen wrench 2.0 mm diameter for colpostat fixation screws — Varian Medical Systems Deutschland GmbH
- Colpostat segments for 20 mm spread, pair — Varian Medical Systems Deutschland GmbH
- Colpostat segments for 25 mm spread, pair — Varian Medical Systems Deutschland GmbH
- Colpostat segments for 30 mm spread, pair — Varian Medical Systems Deutschland GmbH
- Colpostats for 20mm spread, pair — Varian Medical Systems Deutschland GmbH
- Colpostats for 25mm spread, pair — Varian Medical Systems Deutschland GmbH
- Colpostats for 30mm spread, pair — Varian Medical Systems Deutschland GmbH
- Mini-colpostat segments, pair — Varian Medical Systems Deutschland GmbH
- Titanium Fletcher-style Applicator Set Defined Geometry — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Varian Medical Systems Deutschland GmbH
Sources (1)
- FDA UDI c91769bd-6ea4-41be-98b1-1ae8b63e2df4 34 fields · synced May 30, 2026