Identity
- Trade Name
- MALLEABLE LEAD HAND FDA UDI
- Generic Name
- Freestanding patient positioner, reusable FDA UDI
- Model / Reference
- 583030 FDA UDI
Identifiers
- Catalog Number
- 583030 FDA UDI
- Primary DI / UDI-DI
- 00880304394537 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Freestanding patient positioner, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Freestanding patient positioner, reusable
Malleable Lead Hand by Biomet Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Freestanding patient positioner, reusable.
- Inspired by Drive — Drive Devilbiss Healthcare · Class I
- Coulmed — COULMED PRODUCTS GROUP LLC · Class I
- Rayshield — AADCO MEDICAL, INC. · Class I
- Action® — Action Products, Inc. · Class I
- Rayshield — AADCO MEDICAL, INC. · Class I
- PILLING — TELEFLEX INCORPORATED · Class II
- Rayshield — AADCO MEDICAL, INC. · Class I
- Coulmed — COULMED PRODUCTS GROUP 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 | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 53ee772b-9684-4fc1-8480-7149e695527c 34 fields · synced May 30, 2026