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Cervical sleeve, 3 mm aperture, 60 mm length, single use
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Cervical sleeve, 3 mm aperture, 60 mm length, single use FDA UDI
- Generic Name
- Cervical/intrauterine brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- AL13142002 FDA UDI
Identifiers
- Catalog Number
- AL13142002 FDA UDI
- Primary DI / UDI-DI
- 00816389021365 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- Cervical/intrauterine 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
Hydrogen Peroxide FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Length — 60 Millimeter FDA UDI
Category: Cervical/intrauterine brachytherapy system applicator, remote-afterloading
Cervical sleeve, 3 mm aperture, 60 mm length, single use by Varian Medical Systems Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Cervical/intrauterine brachytherapy system applicator, remote-afterloading.
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- Best Medical International — Best Medical International, Inc. · Class I
- Vienna Ring CT/MR Applicator — Nucletron B.V. · Class II
- Fletcher Williamson Applicator — Nucletron B.V. · Class II
- Fletcher Williamson Applicator — Nucletron B.V. · Class II
Cleared under the same submission
K172675 also covers:
K955844 also covers:
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 fbb0c494-db12-416d-8528-f1bc61bcaed0 35 fields · synced May 30, 2026