Identity
- Trade Name
- 3.2mm Guide Wire 395mm FDA UDI
- Generic Name
- Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI
- Device Name
- 3.2mm Guide Wire 395mm FDA UDI
- Model / Reference
- 202-80202 FDA UDI
- Description
- 3.2mm Guide Wire 395mm FDA UDI
Identifiers
- Catalog Number
- 202-80202 FDA UDI
- Primary DI / UDI-DI
- 00810097801202 FDA UDI
- FDA Product Code
- OUR FDA UDI
- GMDN Term
- Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3.2 Millimeter FDA UDILength — 395 Millimeter FDA UDI
Category: Sacroiliac joint transarticular fixation/arthrodesis implantation kit
3.2mm Guide Wire 395mm by OsteoCentric Technologies, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sacroiliac joint transarticular fixation/arthrodesis implantation kit.
- SAMBA SCREW SYSTEM — MEDICAL DESIGNS LLC · Class II
- Zavation Medical Products, LLC — ZAVATION · Class I
- BowTie SI Fusion System — SAIL FUSION · Class I
- BowTie SI Fusion System — SAIL FUSION · Class I
- Radiolucent Instrument Set (No Disposables) Tray System — Si-Bone Inc. · Class I
- Guide Pin Extension Cap - 80mm — Si-Bone Inc. · Class I
- Xenix Medical Sacroiliac Fixation System — Xenix Medical · Class II
- Zavation Medical Products, LLC — ZAVATION · 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
- OsteoCentric Technologies, Inc
Sources (1)
- FDA UDI 273c3ea4-332f-4ad1-b8a1-e190260b658f 36 fields · synced May 30, 2026