FDA UDI In Commercial Distribution 🇺🇸 United States

FLUOROMAP

DI: 07613252196259 · Model: 81-81022 · Stryker Leibinger GmbH & Co. KG
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
FLUOROMAP
Primary DI
07613252196259
Version / Model
81-81022
Catalog Number
81-81022
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
2025-01-28
Public Version
1
Public Version Date
2025-02-05
Public Version Status
New
Public Device Record Key
d2e8808b-25a6-4fb0-b884-d3f0dbbae131

Device Description

FLUOROMAP 1.0 - SALES DEMO CD

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
LLZ System, image processing, radiological
OLO Orthopedic stereotaxic instrument

GMDN Terms

Code Name
42895 Robotic surgical navigation system application software

Identifiers

Type ID
Primary 07613252196259