Identity
- Trade Name
- Handle for lever FDA UDI
- Generic Name
- Cervical/intrauterine brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- GM11009930 FDA UDI
Identifiers
- Catalog Number
- GM11009930 FDA UDI
- Primary DI / UDI-DI
- 00816389025127 FDA UDI
- 510(k) Number
- K980576 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
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
MR Conditional FDA UDI
Category: Cervical/intrauterine brachytherapy system applicator, remote-afterloading
Handle for lever by Varian Medical Systems Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cervical/intrauterine brachytherapy system applicator, remote-afterloading.
- Ring CT/MR Applicator — Nucletron B.V. · Class II
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- Utrecht Interstitial Fletcher CT/MR Applicator — Nucletron B.V. · Class II
- Utrecht Interstitial Fletcher CT/MR Applicator — Nucletron B.V. · Class II
- Best Medical International — Best Medical International, Inc. · Class I
- Vienna Ring CT/MR Applicator — Nucletron B.V. · Class II
- Fletcher Williamson Applicator — Nucletron B.V. · Class II
- Fletcher Williamson Applicator — Nucletron B.V. · Class II
Cleared under the same submission
K980576 also covers:
- Clamping unit for endometrial applicator — Varian Medical Systems Deutschland GmbH
- Grub screws for clamping unit (pack of 10) — Varian Medical Systems Deutschland GmbH
- Intrauterine tandem, center, 320 mm length, straight — Varian Medical Systems Deutschland GmbH
- Intrauterine tandems, right and left, 320 mm length, angle 20 degrees x 50 mm — Varian Medical Systems Deutschland GmbH
- Intrauterine tandems, right and left, 320 mm length, angle 20 degrees x 60 mm — Varian Medical Systems Deutschland GmbH
- Intrauterine tandems, right and left, 320 mm length, angle 20 degrees x 70 mm — Varian Medical Systems Deutschland GmbH
- Intrauterine tandems, right and left, 320 mm length, angle 20 degrees x 80 mm — Varian Medical Systems Deutschland GmbH
- Intrauterine tandems, right and left, 320 mm length, angle 20 degrees x 90 mm — Varian Medical Systems Deutschland GmbH
- Universal Endometrial Applicator Set — Varian Medical Systems Deutschland GmbH
- Vaginal Cylinder with lever, 30 mm diameter x 50 mm length — 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 48b4eca0-2f7b-437e-ba57-33cf0854452e 34 fields · synced May 30, 2026