FDA UDI In Commercial Distribution 🇺🇸 United States

n.a.

DI: 04048551409923 · Model: 41335W · Karl Storz GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5

Basic Information

Brand Name
n.a.
Primary DI
04048551409923
Version / Model
41335W
Company Name
Karl Storz GmbH & Co. KG
Labeler DUNS
315731430
Distribution Status
In Commercial Distribution
Device Count in Pkg
5
Record Status
Published
Publish Date
2020-01-11
Public Version
1
Public Version Date
2020-01-20
Public Version Status
New
Public Device Record Key
729f3d72-f076-4b86-a71b-d38837450c50

Device Description

Sinus Burr 35k, sterile, 5x

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
EQJ BUR, EAR, NOSE AND THROAT

GMDN Terms

Code Name
45527 Diamond ENT bur, single-use

Identifiers

Type ID
Primary 04048551409923
Unit of Use 04048551414972