Identity
- Trade Name
- Sterilization plug, black (pack of 25) FDA UDI
- Generic Name
- Brachytherapy injection needle FDA UDI
- Model / Reference
- GM11009590 FDA UDI
Identifiers
- Catalog Number
- GM11009590 FDA UDI
- Primary DI / UDI-DI
- 10816389027210 FDA UDI
- 510(k) Number
- K073133 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
No
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: Brachytherapy injection needle
Sterilization plug, black (pack of 25) 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.
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- 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
K073133 also covers:
- Stainless steel needle 113 mm, 17 gauge, trocar point — Varian Medical Systems Deutschland GmbH
- Stainless steel needle 113 mm, 18 gauge, trocar point, VariSource only — Varian Medical Systems Deutschland GmbH
- Stainless steel needle 200 mm, 17 gauge, trocar point — Varian Medical Systems Deutschland GmbH
- Stainless steel needle 200 mm, 18 gauge, trocar point, VariSource only — Varian Medical Systems Deutschland GmbH
- Stainless steel needle 250 mm, 17 gauge, trocar point — Varian Medical Systems Deutschland GmbH
- Stainless steel needle 250 mm, 18 gauge, trocar point, VariSource only — Varian Medical Systems Deutschland GmbH
- Stainless steel needle 320 mm, 17 gauge, trocar point — Varian Medical Systems Deutschland GmbH
- Stainless steel needle 320 mm, 18 gauge, trocar point, VariSource only — 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 a23070b2-0d7b-4cf4-8ac6-63b9e5b4b75b 34 fields · synced May 30, 2026