Identity
- Trade Name
- Smit Sleeve 20mm FDA UDI
- Generic Name
- Cervical/intrauterine brachytherapy system applicator, manual FDA UDI
- Device Name
- Smit Sleeve 20mm FDA UDI
- Model / Reference
- 7001 FDA UDI
- Description
- Smit Sleeve 20mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- B1657001327022825052 FDA UDI
- FDA Product Code
- IWJ FDA UDI
- GMDN Term
- Cervical/intrauterine brachytherapy system applicator, manual FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.5650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cervical/intrauterine brachytherapy system applicator, manual
Smit Sleeve 20mm by Liberty Medical Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cervical/intrauterine brachytherapy system applicator, manual.
- Vienna Buildup Cap 7.5mmx2.0mm Natural — MICK RADIO NUCLEAR INSTRUMENT, INC · Class II
- CT/MR Split-Ring, IU Tube, 45øx6cm, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC · Class II
- CT/MR Split-Rng IU Tube, 45øx7cm, Varian — MICK RADIO NUCLEAR INSTRUMENT, INC · Class II
- CT/MR Split-Rng IU Tube, 45øx8cm, Varian — MICK RADIO NUCLEAR INSTRUMENT, INC · Class II
- CT/MR Split-Rng IU Tube, 45øx5cm, Varian — MICK RADIO NUCLEAR INSTRUMENT, INC · Class II
- CT/MR Split-Rng B-U, 10mmx10mm, reus, SET — MICK RADIO NUCLEAR INSTRUMENT, INC · Class II
- CT/MR Split-Ring, IU Tube, 30øx6cm, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC · Class II
- Needle Collector 60deg for 2mm Needle — MICK RADIO NUCLEAR INSTRUMENT, INC · Class II
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Liberty Medical Inc
Sources (1)
- FDA UDI 24bdb863-7435-46eb-81ee-1f6509495ece 33 fields · synced May 30, 2026