Identity
- Trade Name
- Novo Surgical FDA UDI
- Generic Name
- Pinwheel aesthesiometer FDA UDI
- Device Name
- zenith wartenberg neurological pin wheel, 7" (17.8 cm) FDA UDI
- Model / Reference
- G95541-36 FDA UDI
- Description
- zenith wartenberg neurological pin wheel, 7" (17.8 cm) FDA UDI
Identifiers
- Catalog Number
- G95541-36 FDA UDI
- Primary DI / UDI-DI
- G586G95541360 FDA UDI
- FDA Product Code
- GWY FDA UDI
- GMDN Term
- Pinwheel aesthesiometer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 882.1750 FDA UDI
- Commercial Distribution
- 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
Yes
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
Category: Pinwheel aesthesiometer
Novo Surgical by Novo Surgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pinwheel aesthesiometer.
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- WARTENBERG PIN WHEEL — SONTEC INSTRUMENTS, INC. · Class I
- BR Surgical, LLC — BR SURGICAL LLC · Class I
- ORTHOMED — ORTHO-MED, INC. · Class I
- gSource — GSOURCE, LLC. · Class I
- Integra® Jarit® — Integra LifeSciences Production Corporation · Class I
- V. Mueller — STERIS CORPORATION · Class I
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 |
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Manufacturer
- Manufacturer
- Novo Surgical, Inc.
Sources (1)
- FDA UDI ddcfa8bd-97dd-46a2-96b0-4d3d252ad1f1 35 fields · synced Jun 8, 2026