Identity
- Trade Name
- Titanium needle 113 mm, 17 gauge, trocar point FDA UDI
- Generic Name
- Brachytherapy injection needle FDA UDI
- Model / Reference
- GM11009700 FDA UDI
Identifiers
- Catalog Number
- GM11009700 FDA UDI
- Primary DI / UDI-DI
- 00816389024953 FDA UDI
- 510(k) Number
- K093291 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 113 Millimeter FDA UDI
Category: Brachytherapy injection needle
Titanium needle 113 mm, 17 gauge, trocar point by Varian Medical Systems Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Brachytherapy injection needle.
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- Stellar Medical — Stellar Medical, LLC · Class II
- Best Medical International — Best Medical International, Inc. · Class II
Cleared under the same submission
K093291 also covers:
- Titanium needle 113 mm, 16 gauge (1.65 mm), blunt trocar point — Varian Medical Systems Deutschland GmbH
- Titanium needle 113 mm, 16 gauge (1.65 mm), sharp trocar point — Varian Medical Systems Deutschland GmbH
- Titanium needle 200 mm, 16 gauge (1.65 mm), blunt trocar point — Varian Medical Systems Deutschland GmbH
- Titanium needle 200 mm, 16 gauge (1.65 mm), sharp trocar point — Varian Medical Systems Deutschland GmbH
- Titanium needle 200 mm, 17 gauge, trocar point — Varian Medical Systems Deutschland GmbH
- Titanium needle 250 mm, 16 gauge (1.65 mm), blunt trocar point — Varian Medical Systems Deutschland GmbH
- Titanium needle 250 mm, 16 gauge (1.65 mm), sharp trocar point — Varian Medical Systems Deutschland GmbH
- Titanium needle 250 mm, 17 gauge, trocar point — Varian Medical Systems Deutschland GmbH
- Titanium needle 320 mm, 16 gauge (1.65 mm), blunt trocar point — Varian Medical Systems Deutschland GmbH
- Titanium needle 320 mm, 16 gauge (1.65 mm), sharp trocar point — Varian Medical Systems Deutschland GmbH
- Titanium needle 320 mm, 17 gauge, trocar point — 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 2eff8c05-ea5e-4b22-b74e-90a87ecca1a0 35 fields · synced May 30, 2026