AccessGUDID - DEVICE: SELECT ONE (10653405012191)

GUDID

Device Identifier (DI) Information

Brand Name: SELECT ONE
Version or Model: 60-6050-894
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 60-6050-894
Company Name: Conmed Corporation

Primary DI Number: 10653405012191
Issuing Agency: GS1
Commercial Distribution End Date: December 08, 2020
Device Count: 4
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: SELECT ONE LAPAROSCOPIC PROCEDURE PACK

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?
44096	Laparoscopic surgical procedure kit, non-medicated, single-use	A collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOD	CATHETER, UROLOGICAL

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -20 and 140 Degrees Fahrenheit
Handling Environment Temperature: between 60 and 80 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 16 and 27 Degrees Celsius
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit
Handling Environment Humidity: less than 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 32 Degrees Celsius
Handling Environment Temperature: between -29 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4de9ac96-aa0a-464a-aeac-3f9b71213741
Public Version Date: December 08, 2020
Public Version Number: 3
DI Record Publish Date: September 24, 2016