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Plastic needle, 2.0 mm diameter, 113 mm length with mandrin for 113 mm needles
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Plastic needle, 2.0 mm diameter, 113 mm length with mandrin for 113 mm needles FDA UDI
- Generic Name
- Brachytherapy injection needle FDA UDI
- Model / Reference
- GM11007560 FDA UDI
Identifiers
- Catalog Number
- GM11007560 FDA UDI
- Primary DI / UDI-DI
- 00816389024243 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 320 Millimeter FDA UDI
Category: Brachytherapy injection needle
Plastic needle, 2.0 mm diameter, 113 mm length with mandrin for 113 mm needles by Varian Medical Systems Deutschland GmbH — Class II — MDR, FDA UDI — listed…
Similar devices
Also classified as Brachytherapy injection needle.
- Best Medical International — Best Medical International, Inc. · Class I
- RIVERPOINT BRACHYTHERAPY — RIVERPOINT MEDICAL LLC · Class II
- Best Medical International — Best Medical International, Inc. · Class II
- 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
- Protection caps, blue (pack of 20) — 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI 2b6b0d51-7cb9-47b5-8852-f3b093791f59 35 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 2, 2026