FDA UDI In Commercial Distribution 🇺🇸 United States

ORTHOMAP

DI: 07613252433538 · Model: 6003-672-300 · Stryker Leibinger GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ORTHOMAP
Primary DI
07613252433538
Version / Model
6003-672-300
Catalog Number
6003-672-300
Company Name
Stryker Leibinger GmbH & Co. KG
Labeler DUNS
316153956
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-08-24
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
d994f5a0-2936-4e4c-a45a-8df86ff3419a

Device Description

ORTHOMAP¿ EXPRESS KNEE 2.0 - ENABLE

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
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
No

Product Codes

Code Name
OLO Orthopedic stereotaxic instrument

GMDN Terms

Code Name
42895 Robotic surgical navigation system application software

Identifiers

Type ID
Primary 07613252433538