Identity
- Trade Name
- Geminus FDA UDI
- Generic Name
- Periosteal elevator, reusable FDA UDI
- Model / Reference
- Instrument, Key Periosteal Elevator, Standard FDA UDI
Identifiers
- Catalog Number
- INST-KPE-STD FDA UDI
- Primary DI / UDI-DI
- 00841506102450 FDA UDI
- 510(k) Number
- K111620 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Periosteal elevator, 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: Periosteal elevator, 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 Periosteal elevator, reusable.
- Ambler Surgical — Ambler Surgical, LLC · Class I
- STERLING — BENCO DENTAL SUPPLY CO. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- SCANLAN® Instrumentation — SCANLAN INTERNATIONAL INC · Class I
- BARRIER PLACEMENT INSTRUMENT — W.H. Holden, Inc. · Class I
- ELEVATOR — KLS-Martin L.P. · Class I
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- Ambler Surgical — Ambler Surgical, LLC · 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 |
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Manufacturer
- Manufacturer
- Skeletal Dynamics L.l.c.
Sources (1)
- FDA UDI 6c618639-e941-40a3-a331-d4a1f42634f6 35 fields · synced May 30, 2026