Identity
- Trade Name
- Excella II® FDA UDI
- Generic Name
- Surgical torque wrench, reusable FDA UDI
- Device Name
- Radel, Silicone, SST FDA UDI
- Model / Reference
- LS-175 FDA UDI
- Description
- Radel, Silicone, SST FDA UDI
Identifiers
- Primary DI / UDI-DI
- M711LS1750 FDA UDI
- 510(k) Number
- K102248 FDA UDI
- FDA Product Code
- NKB FDA UDIMNI FDA UDIMNH FDA UDIKWP FDA UDIKWQ FDA UDI
- GMDN Term
- Surgical torque wrench, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3050 FDA UDI888.3060 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical torque wrench, reusable
Excella II® by Innovasis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical torque wrench, reusable.
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- OXFORD ANKLE FUSION NAIL(AFN) SYSTEM — ORTHO SOLUTIONS HOLDINGS LIMITED · Class II
- X FIX — Biomet Orthopedics, Inc. · Class I
- BIONNOVATION — BIONNOVATION PRODUTOS BIOMEDICOS LTDA. · Class I
Cleared under the same submission
K102248 also covers:
- Excella 3® — Innovasis, Inc.
- Excella 3® — Innovasis, Inc.
- Excella 3® — Innovasis, Inc.
- Excella 3® — Innovasis, Inc.
- Excella 3® — Innovasis, Inc.
- Excella 3® — Innovasis, Inc.
- Excella 3® — Innovasis, Inc.
- Excella 3® — Innovasis, Inc.
- Excella 3® — Innovasis, Inc.
- Excella 3® — Innovasis, Inc.
- Excella 3™ — Innovasis, Inc.
- Excella 3™ — Innovasis, Inc.
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
- Innovasis, Inc.
Sources (1)
- FDA UDI 91c96a09-ed0f-4d62-aa15-2827899c33a9 35 fields · synced Jun 1, 2026