FDA UDI In Commercial Distribution 🇺🇸 United States

n.a.

DI: 04048551389102 · Model: TH001 · Karl Storz GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10

Basic Information

Brand Name
n.a.
Primary DI
04048551389102
Version / Model
TH001
Company Name
Karl Storz GmbH & Co. KG
Labeler DUNS
315731430
Distribution Status
In Commercial Distribution
Device Count in Pkg
10
Record Status
Published
Publish Date
2019-02-23
Public Version
2
Public Version Date
2020-02-06
Public Version Status
Update
Public Device Record Key
0e3e7fd8-caff-43b5-8204-d17977fa0d23

Device Description

Cover for VITOM 3D

Device Characteristics

Single Use
Yes
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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
EPT MICROSCOPE, SURGICAL

GMDN Terms

Code Name
12535 Medical equipment drape, single-use

Identifiers

Type ID
Primary 04048551389102
Unit of Use 04048551389119