AccessGUDID - DEVICE: SELECT ONE (10653405043584)

GUDID

Device Identifier (DI) Information

Brand Name: SELECT ONE
Version or Model: 1-6048
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1-6048
Company Name: Conmed Corporation

Primary DI Number: 10653405043584
Issuing Agency: GS1
Commercial Distribution End Date: October 10, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: SELECT ONE LAPAROSCOPIC KIT

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
FDE	laparoscopy kit

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 [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 32 Degrees Celsius
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Bladed/Shielded Trocar
Device Size Text, specify: Bladed/Shielded Surgical Trocar
Device Size Text, specify: Blunt Tip Trocar
Device Size Text, specify: Universal Converter
Device Size Text, specify: Sleeve
Device Size Text, specify: Pneumoperitoneum Insufflation Needle

Device Record Status

Public Device Record Key: 8931a53c-9f77-499d-b927-032b04c1030d
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016