AccessGUDID - DEVICE: CONMED (10653405005780)

GUDID

Device Identifier (DI) Information

Brand Name: CONMED
Version or Model: 60-3950-031
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60-3950-031
Company Name: Conmed Corporation

Primary DI Number: 10653405005780
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: ARTHROSCOPY CAMERA DRAPE 5" (12.7 CM) X 96" (244 CM)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
12143	Instrument tray, reusable	A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KQM	CAMERA, SURGICAL AND ACCESSORIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: KEEP DRY

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 5 Inch
Outer Diameter: 12.7 Centimeter
Length: 96 Inch
Length: 244 Centimeter

Device Record Status

Public Device Record Key: e6af8488-36b7-4fad-b773-f5c3982d4a40
Public Version Date: August 02, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2020