Identity
- Trade Name
- Protection caps, blue (pack of 20) FDA UDI
- Generic Name
- Brachytherapy injection needle FDA UDI
- Model / Reference
- GM11007660 FDA UDI
Identifiers
- Catalog Number
- GM11007660 FDA UDI
- Primary DI / UDI-DI
- 10816389027180 FDA UDI
- 510(k) Number
- K141624 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- Brachytherapy injection needle 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
Yes
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
MR Unsafe FDA UDI
Category: Brachytherapy injection needle
Protection caps, blue (pack of 20) by Varian Medical Systems Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Brachytherapy injection needle.
- Best Medical International — Best Medical International, Inc. · Class I
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- Advantage-Strand® and Advantage-Load® with Advantage I-125® — ISOAID, L.L.C. · Class II
- GOLD FIDUCIAL MARKER — RIVERPOINT MEDICAL LLC · Class II
- Stellar Medical — Stellar Medical, LLC · Class II
- Stellar Medical — Stellar Medical, LLC · Class II
- Best Medical International — Best Medical International, Inc. · Class II
Cleared under the same submission
K141624 also covers:
- Accessory Kit - "Light" Version for Interstitial Applicators — Varian Medical Systems Deutschland GmbH
- Basic Accessory Kit for Interstitial Applicators — Varian Medical Systems Deutschland GmbH
- Basic Accessory Kit for Intracavitary/GYN Applicators, GammaMed — Varian Medical Systems Deutschland GmbH
- Basic accessory kit for intracavitary / GYN applicators, VariSource — Varian Medical Systems Deutschland GmbH
- Complete Accessory Kit for Interstitial Applicators — Varian Medical Systems Deutschland GmbH
- Mandrin for 113mm length Needle — Varian Medical Systems Deutschland GmbH
- Plastic needle 2.0 mm diameter, 200 mm length with mandrin for 200 mm needles — Varian Medical Systems Deutschland GmbH
- Plastic needle 2.0 mm diameter, 320 mm length, blunt tip w/ mandrin — Varian Medical Systems Deutschland GmbH
- Plastic needle ø 2.0 mm diameter, 320 mm length with mandrin for 320 mm needles — Varian Medical Systems Deutschland GmbH
- Plastic needle, 2.0 mm diameter, 113 mm length with mandrin for 113 mm needles — Varian Medical Systems Deutschland GmbH
- Stainless steel button for needle 1.6 - 2.0 mm diameter, including M4 nut — 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 99b5f465-01c0-4c6b-bf61-7fb3f0d18d73 34 fields · synced Jun 1, 2026