Identity
- Trade Name
- Pivot Guardian FDA UDI
- Generic Name
- Surgical counter-traction post FDA UDI
- Device Name
- PostFree Perineal Accessory Kit FDA UDI
- Model / Reference
- 3105000950 FDA UDI
- Description
- PostFree Perineal Accessory Kit FDA UDI
Identifiers
- Catalog Number
- 3105-000-950 FDA UDI
- Primary DI / UDI-DI
- 07613327380378 FDA UDI
- FDA Product Code
- HST FDA UDI
- GMDN Term
- Surgical counter-traction post FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.5850 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical counter-traction post
Pivot Guardian by Stryker Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical counter-traction post.
- Arthrex® — Arthrex, Inc. · Class I
- Schaerer Medical USA — Schaerer Medical Usa, Inc. · Class I
- LATERAL PERINEAL POST, CURVED — Mizuho Orthopedic Systems, Inc. · Class I
- Schaerer Medical USA — Schaerer Medical Usa, Inc. · Class I
- Schaerer Medical USA — Schaerer Medical Usa, Inc. · Class I
- ADANTE EXTENDED SADDLE POST — Mizuho Orthopedic Systems, Inc. · Class I
- HANA/PROFX ADULT PERINEAL POST, REFURBISHED — Mizuho Orthopedic Systems, Inc. · Class I
- Schaerer Medical USA — Schaerer Medical Usa, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Stryker Corp.
Sources (1)
- FDA UDI 3abfe3f3-b2a0-4b33-87e3-95ed4fc3fc28 35 fields · synced May 30, 2026