FDA UDI In Commercial Distribution 🇺🇸 United States

n.a.

DI: 04048551010235 · Model: 497HC · 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
04048551010235
Version / Model
497HC
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
2016-09-23
Public Version
3
Public Version Date
2021-01-08
Public Version Status
Update
Public Device Record Key
9d99db94-acc8-4729-8748-4c8af1dd6413

Device Description

HAVAS Light Carrier

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
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
Yes
Sterilization Methods
["Moist Heat or Steam Sterilization", "Hydrogen Peroxide", "Peracetic Acid", "Ethylene Oxide"]

Product Codes

Code Name
FCW Light source, fiberoptic, routine

GMDN Terms

Code Name
36843 Mobile examination/treatment room light

Identifiers

Type ID
Primary 04048551010235