FDA UDI Not in Commercial Distribution 🇺🇸 United States

LinkStation MINI Evaluation Kit

DI: 00816818020518 · Model: LinkStation MINI Evaluation Kit · ORTHOSENSOR INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
LinkStation MINI Evaluation Kit
Primary DI
00816818020518
Version / Model
LinkStation MINI Evaluation Kit
Catalog Number
05000-502
Company Name
ORTHOSENSOR INC
Labeler DUNS
005788130
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-02-20
Public Version
6
Public Version Date
2023-07-31
Public Version Status
Update
Public Device Record Key
59d6b3c7-158a-40bd-942e-668d5d2c8add
Distribution End Date
2023-06-30

Device Description

LinkStation MINI Evaluation Kit with Australia and New Zealand power cord

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
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
ONN Intraoperative Orthopedic Joint Assessment Aid

GMDN Terms

Code Name
62563 Arthroplasty force sensor display unit

Identifiers

Type ID
Primary 00816818020518