Identity
- Trade Name
- Tecomet FDA UDI
- Generic Name
- Endoscopic surgical probe FDA UDI
- Device Name
- Sounder BLANK, Straight .045/.065 FDA UDI
- Model / Reference
- SP101179 FDA UDI
- Description
- Sounder BLANK, Straight .045/.065 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818069016746 FDA UDI
- FDA Product Code
- HXB FDA UDI
- GMDN Term
- Endoscopic surgical probe 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Endoscopic surgical probe
Tecomet by Tecomet, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic surgical probe.
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- Novo Surgical — NOVO SURGICAL, INC. · Class I
- MaxMoreSpine — Hoogland Spine Products, GmbH · Class I
- Lightning — RESPONSIVE ORTHOPEDICS LLC · Class I
- Rasp Probe — Biomet Orthopedics, Inc. · Class I
- Lightning — RESPONSIVE ORTHOPEDICS LLC · Class I
- Ambler Surgical — Ambler Surgical, 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 |
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Manufacturer
- Manufacturer
- Tecomet, Inc
Sources (1)
- FDA UDI 79d74e99-1919-46ab-99b6-aa11ad9dbcd5 33 fields · synced Sep 18, 2026