Identity
- Trade Name
- ALP STRAPS W/FOAM BOOTS (PR) FDA UDI
- Generic Name
- Limb/torso/head restraint, single-use FDA UDI
- Device Name
- Operating Table Accessories EUDAMED
- Model / Reference
- 5052-3 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 5052-3 FDA UDI
- Primary DI / UDI-DI
- 00842430105807 EUDAMEDFDA UDI
- Basic UDI-DI
- 0842430158956Y EUDAMED
- FDA Product Code
- JEA FDA UDI
- EMDN Code
- Z12011285 PATIENT POSITIONING INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Limb/torso/head restraint, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4960 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Limb/torso/head restraint, single-use
Alp Straps W/Foam Boots (pr) by Mizuho Orthopedic Systems, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Limb/torso/head restraint, single-use.
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- Bosma Enterprises — Bosma Enterprises · Class I
- MORRISON MEDICAL — MORRISON MEDICAL, LTD · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- Protective Mitt — KENAD SG MEDICAL, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mizuho Orthopedic Systems, Inc.
Sources (2)
- FDA UDI 56e1e962-1884-47c2-9534-70dbbfe79b6c 34 fields · synced Jun 19, 2026
- EUDAMED 7c1acb18-aca2-48f2-9f34-f71ddc521a61 61 fields · synced Jun 19, 2026