FDA UDI In Commercial Distribution 🇺🇸 United States

TIPCAM1

DI: 04048551347843 · Model: 26605BA · Karl Storz GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
TIPCAM1
Primary DI
04048551347843
Version / Model
26605BA
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
4
Public Version Date
2021-11-23
Public Version Status
Update
Public Device Record Key
7d132a8c-903a-44a3-aff3-ab6d1ddfa4e7

Device Description

TIPCAM®1 S 3D LAP, 30°

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
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", "Moist Heat or Steam Sterilization"]

Product Codes

Code Name
FGB Ureteroscope and accessories, flexible/rigid

GMDN Terms

Code Name
43053 Rigid video laparoscope

Identifiers

Type ID
Primary 04048551347843

Premarket Submissions

Submission Number Supplement Number
K150525 000