FDA UDI In Commercial Distribution 🇺🇸 United States

n.a.

DI: 04048551090695 · Model: 278A · 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
04048551090695
Version / Model
278A
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
2018-07-06
Public Version Status
Update
Public Device Record Key
7f87a436-d390-41d5-9cec-265a55b64100

Device Description

Monopolar Cord, length 300 cm

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
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

Product Codes

Code Name
GEI ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

GMDN Terms

Code Name
47487 Electrical-only medical device connection cable, reusable

Identifiers

Type ID
Primary 04048551090695

Premarket Submissions

Submission Number Supplement Number
K945380 000