Identity
- Trade Name
- 4.7 Fr. plastic-tipped catheter, 150 cm FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- AL13115000 FDA UDI
Identifiers
- Catalog Number
- AL13115000 FDA UDI
- Primary DI / UDI-DI
- 00816389021280 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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 Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 150 Centimeter FDA UDI
Category: General-purpose brachytherapy system applicator, remote-afterloadingBronchial brachytherapy system applicator, remote-afterloading
4.7 Fr. plastic-tipped catheter, 150 cm by Varian Medical Systems Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K171631 also covers:
K952913 also covers:
- 4.7 Fr. metal-tipped catheter, 100 cm — Varian Medical Systems Deutschland GmbH
- 4.7 Fr. metal-tipped catheter, 150 cm — Varian Medical Systems Deutschland GmbH
- 4.7 Fr. plastic-tipped catheter, 100 cm — Varian Medical Systems Deutschland GmbH
- APPLICATOR WRENCH (CT/MR FSD) — Varian Medical Systems Deutschland GmbH
- CERVICAL STOP (CT/MR FSD) — Varian Medical Systems Deutschland GmbH
- CLAMP SPREAD BLOCK (CT/MR FSD) — Varian Medical Systems Deutschland GmbH
- Measurement marker clip — Varian Medical Systems Deutschland GmbH
- Ovoid pair, 20 mm diameter — Varian Medical Systems Deutschland GmbH
- Ovoid pair, 25 mm diameter — Varian Medical Systems Deutschland GmbH
- Ovoid pair, mini 16 mm diameter — Varian Medical Systems Deutschland GmbH
- PIVOT SCREW (CT/MR FSD) — Varian Medical Systems Deutschland GmbH
- PIVOT SCREW BTM (CT/MR FSD) — 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 ec907a39-6896-40c2-96ae-96f4157f51b5 35 fields · synced Jun 8, 2026