FDA UDI In Commercial Distribution 🇺🇸 United States

n.a.

DI: 04048551221723 · Model: 9530BD · Karl Storz GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
n.a.
Primary DI
04048551221723
Version / Model
9530BD
Company Name
Karl Storz GmbH & Co. KG
Labeler DUNS
315731430
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-02-23
Public Version
1
Public Version Date
2019-03-11
Public Version Status
New
Public Device Record Key
19d2cddf-d3e3-4537-9535-6e5ecf685630

Device Description

Integral Rotating Beamsplitter

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
Yes
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
Yes
Sterilization Methods
["Hydrogen Peroxide", "Ethylene Oxide", "Peracetic Acid", "High-level Disinfectant"]

Product Codes

Code Name
EPT MICROSCOPE, SURGICAL

GMDN Terms

Code Name
32287 Surgical camera lens

Identifiers

Type ID
Primary 04048551221723