FDA UDI In Commercial Distribution 🇺🇸 United States

KATANA

DI: 20845854050672 · Model: GU1009F · Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
KATANA
Primary DI
20845854050672
Version / Model
GU1009F
Catalog Number
GU1009F
Company Name
Conmed Corporation
Labeler DUNS
071595540
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-04-29
Public Version
2
Public Version Date
2019-09-27
Public Version Status
Update
Public Device Record Key
321b1470-592b-4f63-a1fc-8e17967eacbd

Device Description

Katana Flush Cutter

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
Yes
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
LXH ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

GMDN Terms

Code Name
16224 Suture cutter, reusable

Identifiers

Type ID
Primary 20845854050672
Direct Marking 10845854050675

Customer Contacts

Device Sizes

Type Value Unit Text
Device Size Text, specify 142 X 4.0 MM

Storage Conditions

Type
Special Storage Condition, Specify
Special Conditions
KEEP DRY