FDA UDI Not in Commercial Distribution 🇺🇸 United States

Alignment Instrument, Triple End

DI: 00851599007488 · Model: 201.040.30 · JACE MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Alignment Instrument, Triple End
Primary DI
00851599007488
Version / Model
201.040.30
Company Name
JACE MEDICAL, LLC
Labeler DUNS
063554875
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-08-15
Public Version
3
Public Version Date
2023-02-03
Public Version Status
Update
Public Device Record Key
7b24b827-afc2-4084-8ab5-1ad3e9ac7990
Distribution End Date
2022-12-31

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
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
HRS Plate, Fixation, Bone

GMDN Terms

Code Name
47870 Orthopaedic fixation implant alignment tool

Identifiers

Type ID
Primary 00851599007488