FDA UDI In Commercial Distribution 🇺🇸 United States

n.a.

DI: 04048551395653 · Model: 28164FGL-S · Karl Storz GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2

Basic Information

Brand Name
n.a.
Primary DI
04048551395653
Version / Model
28164FGL-S
Company Name
Karl Storz GmbH & Co. KG
Labeler DUNS
315731430
Distribution Status
In Commercial Distribution
Device Count in Pkg
2
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
ca14c9d5-7752-40d1-b12a-999a696a97b1

Device Description

INSERT, MICRO FORCEPS F/USE W/28164BGL

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
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
GEI ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

GMDN Terms

Code Name
32684 Endoscopic electrosurgical handpiece/electrode, bipolar, reusable

Identifiers

Type ID
Primary 04048551395653
Unit of Use 04048551395660

Premarket Submissions

Submission Number Supplement Number
K936036 000