Identity
- Trade Name
- PROBE FDA UDI
- Generic Name
- Endoscopic surgical probe FDA UDI
- Model / Reference
- 901010 FDA UDI
Identifiers
- Catalog Number
- 901010 FDA UDI
- Primary DI / UDI-DI
- 00880304402003 FDA UDI
- 510(k) Number
- K933070 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Endoscopic surgical probe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 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
No
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
Probe by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic surgical probe.
- Tecomet — Tecomet,Inc · Class I
- ENDOTRAC — Stryker Corp. · Class II
- MAGNETIC PROBE — SONTEC INSTRUMENTS, INC. · Class I
- Tecomet — Tecomet,Inc · Class I
- Novo Surgical — NOVO SURGICAL, INC. · Class I
- MaxMoreSpine — Hoogland Spine Products, GmbH · Class I
- Lightning — RESPONSIVE ORTHOPEDICS LLC · Class I
- Lightning — RESPONSIVE ORTHOPEDICS LLC · Class I
Cleared under the same submission
K933070 also covers:
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
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 2c8d4a5f-6f4a-4212-9f1b-d8d3dac6296b 35 fields · synced May 30, 2026