Identity
- Trade Name
- Whistler Modular Pedicle Screw System FDA UDI
- Generic Name
- General-purpose calliper, metallic FDA UDI
- Device Name
- Screw Gauge FDA UDI
- Model / Reference
- WI-041 FDA UDI
- Description
- Screw Gauge FDA UDI
Identifiers
- Catalog Number
- WI-041 FDA UDI
- Primary DI / UDI-DI
- 00195860012352 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- General-purpose calliper, metallic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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: General-purpose calliper, metallic
Whistler Modular Pedicle Screw System by Evolution Spine, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose calliper, metallic.
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- Symmetry House — SYMMETRY SURGICAL INC. · Class I
- Salvin Dental Specialties — SALVIN DENTAL SPECIALTIES, LLC · Class I
- CALIPER CASTROVIEJO 40mm FENSTRATED — W.H. Holden, Inc. · Class I
- Integra® Jarit® — Integra LifeSciences Production Corporation · Class I
- CALIPER — KLS-Martin L.P. · Class I
- CALIPER — KLS-Martin L.P. · Class I
- Caliper — BURLINGTON MEDICAL, LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Evolution Spine, Llc
Sources (1)
- FDA UDI 47f26ea6-60ec-4f2a-906a-8e3a9b22072b 35 fields · synced Jun 8, 2026