Identity
- Trade Name
- Pivot Guardian FDA UDI
- Generic Name
- Limb/torso/head restraint, single-use FDA UDI
- Device Name
- Pivot Guardian Direct Disposable Kit Small FDA UDI
- Model / Reference
- 3105000740 FDA UDI
- Description
- Pivot Guardian Direct Disposable Kit Small FDA UDI
Identifiers
- Catalog Number
- 3105-000-740 FDA UDI
- Primary DI / UDI-DI
- 07613327570465 FDA UDI
- FDA Product Code
- HST FDA UDI
- GMDN Term
- Limb/torso/head restraint, single-use 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
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
Category: Limb/torso/head restraint, single-use
Pivot Guardian by Stryker Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 24a54d63-4a24-48ab-b8e0-cd46e2bc1e33 35 fields · synced May 31, 2026