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CT/MR Obturator for Plastic Needle, L= 300 mm (à 1 pc)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- CT/MR Obturator for Plastic Needle, L= 300 mm (à 1 pc) FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- LLH02-300 FDA UDI
Identifiers
- Catalog Number
- LLH02-300 FDA UDI
- Primary DI / UDI-DI
- 04049223114527 FDA UDI
- 510(k) Number
- K142986 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
CT/MR Obturator for Plastic Needle, L= 300 mm (à 1 pc) by Eckert & Ziegler BEBIG GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K142986 also covers:
- Disposable steel needle, 17G, L=200mm — BEBIG Medical GmbH
- 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 (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
- Eckert & Ziegler BEBIG GmbH
Sources (1)
- FDA UDI fc53be53-f776-42fd-8e28-e91b12d50503 36 fields · synced Jun 8, 2026