FDA UDI In Commercial Distribution 🇺🇸 United States

ProAM ALIF System

DI: 00810152903056 · Model: LN-010606-0000 · Pro Surgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ProAM ALIF System
Primary DI
00810152903056
Version / Model
LN-010606-0000
Catalog Number
LN-010606-0000
Company Name
Pro Surgical, Inc.
Labeler DUNS
119149675
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-02-12
Public Version
1
Public Version Date
2025-02-20
Public Version Status
New
Public Device Record Key
1cf0e60b-d760-4235-b907-1c9892cc1025

Device Description

Screwdriver Countertorque

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
LXH Orthopedic Manual Surgical Instrument

GMDN Terms

Code Name
47554 Orthopaedic counter-torque/rod-pushing instrument

Identifiers

Type ID
Primary 00810152903056