FDA UDI In Commercial Distribution 🇺🇸 United States

NA

DI: 30653405009973 · Model: 60-5168-005 · Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50

Basic Information

Brand Name
NA
Primary DI
30653405009973
Version / Model
60-5168-005
Catalog Number
60-5168-005
Company Name
Conmed Corporation
Labeler DUNS
071595540
Distribution Status
In Commercial Distribution
Device Count in Pkg
50
Record Status
Published
Publish Date
2016-09-24
Public Version
5
Public Version Date
2024-02-19
Public Version Status
Update
Public Device Record Key
df787d16-0ede-4ed8-b354-a0a3082a0048

Device Description

Universal Monopolar Laparoscopic Cable 10ft, 4mm Pin Connector

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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
Yes
Sterilization Methods
Ethylene Oxide

Product Codes

Code Name
GCJ Laparoscope, general & plastic surgery

GMDN Terms

Code Name
47143 Electrical-only medical device connection cable, single-use

Identifiers

Type ID
Package 20653405009976
Primary 30653405009973
Unit of Use 00653405009972

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K943327 000

Device Sizes

Type Value Unit Text
Length 3.05 Meter
Length 10 Feet
Outer Diameter 4 Millimeter

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
10 – 32 Degrees Celsius
Type
Storage Environment Temperature
Temperature Range
50 – 90 Degrees Fahrenheit
Type
Storage Environment Humidity
Temperature Range
10 – 90 Percent (%) Relative Humidity