Identity
- Trade Name
- Sgarlato Silastic FDA UDI
- Generic Name
- Surgical implant/trial-implant/sizer holder, single-use FDA UDI
- Device Name
- GAIT Sizer Small FDA UDI
- Model / Reference
- 30-099-01 FDA UDI
- Description
- GAIT Sizer Small FDA UDI
Identifiers
- Catalog Number
- 30-099-01 FDA UDI
- Primary DI / UDI-DI
- 00819034026913 FDA UDI
- FDA Product Code
- KWH FDA UDI
- GMDN Term
- Surgical implant/trial-implant/sizer holder, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3720 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical implant/trial-implant/sizer holder, single-use
Sgarlato Silastic by Fusion Orthopedics, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical implant/trial-implant/sizer holder, single-use.
- MPJ TRIAL 17mm (SM) — BIOPRO, INC. · Class I
- HyperFlex® Bunion Correction System — HyperFlex Medical Inc · Class II
- INHANCE — DEPUY (IRELAND) · Class I
- Nextra Hammertoe Correction System — Medartis Inc. · Class I
- restor3d Disposable Instrument, Cervical Cage Trial — Restor3D · Class I
- restor3d Veritas rTSA Instrumentation — Restor3D · Class II
- G7 SUCTION CUP — Biomet Orthopedics, Inc. · Class I
- Fuji Cervical Plate System — Altus Spine · Class II
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
- Fusion Orthopedics, Llc
Sources (1)
- FDA UDI 24845fe7-acec-4039-ae71-b68cd1a23e47 34 fields · synced May 30, 2026