Identity
- Trade Name
- Geminus FDA UDI
- Generic Name
- Abdominal/ENT/orthopaedic surgical probe, reusable FDA UDI
- Model / Reference
- Instrument, Sharp Hook Probe, Standard FDA UDI
Identifiers
- Catalog Number
- INST-SHP-STD FDA UDI
- Primary DI / UDI-DI
- 00841506102474 FDA UDI
- 510(k) Number
- K111620 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Abdominal/ENT/orthopaedic surgical probe, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
No
FDA UDI
Category: Abdominal/ENT/orthopaedic surgical probe, reusable
Geminus by Skeletal Dynamics L.l.c. — Class II — 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
Cleared under the same submission
K111620 also covers:
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
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
- Skeletal Dynamics L.l.c.
Sources (1)
- FDA UDI 39189bab-addc-4dad-abd7-21cae08b1828 35 fields · synced May 29, 2026