Identity
- Trade Name
- iFIX FDA UDI
- Generic Name
- Limb/torso/head restraint, single-use FDA UDI
- Device Name
- short-term patient stabilization FDA UDI
- Model / Reference
- Kit CT Micromate BP FDA UDI
- Description
- short-term patient stabilization FDA UDI
Identifiers
- Catalog Number
- 58786 FDA UDI
- Primary DI / UDI-DI
- 09010279001173 FDA UDI
- GMDN Term
- Limb/torso/head restraint, single-use FDA UDI
Classification
- 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Limb/torso/head restraint, single-useMedical table restraint anchor
iFIX by iSYS Medizintechnik GmbH — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical table restraint anchor.
- AADCO — AADCO MEDICAL, INC. · Class II
- Blue Diamond — David Scott Company. · Class I
- GRABBER BRACKET — AliMed, LLC · Class I
- ArmGuard™ — DAN ALLEN SURGICAL · Class I
- AADCO — AADCO MEDICAL, INC. · Class II
- Birkova — STERIS CORPORATION · Class I
- AADCO — AADCO MEDICAL, INC. · Class II
- PRIMO/ASP MEDICAL — Asp Global, LLC · 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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- iSYS Medizintechnik GmbH
Sources (1)
- FDA UDI 9895e747-4a3a-4930-973f-86722da806f8 34 fields · synced May 31, 2026