Identity
- Trade Name
- Kaliec Special FDA UDI
- Generic Name
- Abdominal/ENT/orthopaedic surgical probe, reusable FDA UDI
- Device Name
- Probe, 1.75" Egg, Steffee Long Str Imp Crimson FDA UDI
- Model / Reference
- DR-K03-0001 FDA UDI
- Description
- Probe, 1.75" Egg, Steffee Long Str Imp Crimson FDA UDI
Identifiers
- Catalog Number
- DR-K03-0001 FDA UDI
- Primary DI / UDI-DI
- B073DRK0300010 FDA UDI
- FDA Product Code
- HXB FDA UDI
- GMDN Term
- Abdominal/ENT/orthopaedic surgical probe, reusable 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: Abdominal/ENT/orthopaedic surgical probe, reusable
Kaliec Special by Kalitec Direct LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Abdominal/ENT/orthopaedic surgical probe, reusable.
- DRM Thoracic Pedicle Feeler 1 — Captiva Spine · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- ISOLA — Depuy Spine, Inc. · Class I
- Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Invictus — ALPHATEC SPINE, INC. · Class I
- Optima™ Spinal System — CG MedTech Co., Ltd. · Class I
- General Instruments — ALPHATEC SPINE, INC. · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · 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
- Kalitec Direct LLC
Sources (1)
- FDA UDI db43adca-3b7b-4c35-a629-ae0c1d48f9c1 34 fields · synced May 30, 2026