Identity
- Trade Name
- Medline ReNewal FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, reprocessed FDA UDI
- Device Name
- AR-9601SJ-90 @OPES ABLATOR, SM JT, 90 DE FDA UDI
- Model / Reference
- UMAR9601SJ9RH FDA UDI
- Description
- AR-9601SJ-90 @OPES ABLATOR, SM JT, 90 DE FDA UDI
Identifiers
- Catalog Number
- UMAR9601SJ9RH FDA UDI
- Primary DI / UDI-DI
- 10888277380912 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, reprocessed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Angle — 90 degree FDA UDI
Category: Endoscopic electrosurgical handpiece/electrode, monopolar, reprocessed
Medline ReNewal by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electrosurgical handpiece/electrode, monopolar, reprocessed.
- Reprocessed TAC-S Probe, Monopolar — SURETEK MEDICAL · Class II
- Reprocessed Colorado Microdissect Needle, 3.0 x 102mm, 45 Deg — SURETEK MEDICAL · Class II
- Reprocessed Colorado Microdissect Needle, 20mm — SURETEK MEDICAL · Class II
- Reprocessed Ligament Chisel Probe, Curved, Monopolar — SURETEK MEDICAL · Class II
- Reprocessed Colorado Microdissect Needle, 90 Deg Angle — SURETEK MEDICAL · Class II
- Reprocessed Ligament Chisel Probe, Hook, Monopolar — SURETEK MEDICAL · Class II
- Reprocessed MicroNeedle 3cm — SURETEK MEDICAL · Class II
- Reprocessed TAC-C II Probe, Monopolar — SURETEK MEDICAL · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medline Industries, Inc.
Sources (1)
- FDA UDI c436c42e-eb19-416e-85f3-bf197817d3c6 36 fields · synced May 30, 2026