Disposable steel needle, 17G, L=200mm
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Disposable steel needle, 17G, L=200mm EUDAMEDFDA UDI
- Generic Name
- Remote-afterloading brachytherapy system FDA UDI
- Device Name
- Disposable steel needle EUDAMEDThe Disposable Steel Needles are intended for interstitial brachytherapy applications. FDA UDI
- Model / Reference
- LLA210-S EUDAMED05 FDA UDI
- Description
- The Disposable Steel Needles are intended for interstitial brachytherapy applications. FDA UDI
Identifiers
- Catalog Number
- LLA210-S FDA UDI
- Primary DI / UDI-DI
- 04065983002850 EUDAMEDFDA UDI04065983000962 EUDAMED
- Basic UDI-DI
- B-04065983000962 EUDAMEDB-04065983002850 EUDAMED
- 510(k) Number
- K142986 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- A019016,Z11010385 EUDAMED
- GMDN Term
- Remote-afterloading brachytherapy system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Remote-afterloading brachytherapy system
Disposable steel needle, 17G, L=200mm by BEBIG Medical GmbH — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K142986 also covers:
- Easy Click Transfer Tube 6F, D=3mm, L=1000mm — BEBIG Medical GmbH
- Easy Click Transfer Tube, D=3mm, L=1000mm — BEBIG Medical GmbH
- SagiNova® Ir 25 channels, for Ir-192 only — BEBIG Medical GmbH
- Transfer Tube, D=3mm, L=1000mm, Blue, Channel 3 — BEBIG Medical GmbH
- Transfer Tube, D=3mm, L=1000mm, Blue, Channel 3, T-connector — BEBIG Medical GmbH
- Transfer Tube, D=3mm, L=1000mm, Green, Channel 1 — BEBIG Medical GmbH
- Transfer Tube, D=3mm, L=1000mm, Green, Channel 1, T-connector — BEBIG Medical GmbH
- Transfer Tube, D=3mm, L=1000mm, T-connector — BEBIG Medical GmbH
- Transfer Tube, D=3mm, L=1000mm, Yellow, Channel 2 — BEBIG Medical GmbH
- Transfer Tube, D=3mm, L=1000mm, Yellow, Channel 2, T-connector — BEBIG Medical GmbH
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- BEBIG Medical GmbH
Sources (3)
- FDA UDI 08455a2d-254d-4523-b8f8-74eb5b3e570e 35 fields · synced Jul 23, 2026
- EUDAMED 156d52b8-6a96-47ab-9bdd-ec4e7da7f7ee 61 fields · synced Jun 19, 2026
- EUDAMED d627537c-6aad-470a-b3ef-a15fe2e17a0e 61 fields · synced Jul 23, 2026