AccessGUDID - DEVICE: Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX (03701354402201)

GUDID

Device Identifier (DI) Information

Brand Name: Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX
Version or Model: PW C-G-D 90
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PLASMABIOTICS

Primary DI Number: 03701354402201
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 262972663 *Terms of Use

Device Description: Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX 90 and i10 series

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
61446	Cochlear electrode array introducer, reusable	A non-sterile, hand-held manual surgical instrument designed to aid insertion of an electrode array into the cochlea during implantation of a cochlear implant. It is typically a thin probe with a clawed distal end mounted on a handle and is made of high-grade stainless steel. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 40 Degrees Celsius
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between .9 and 1.1 Inches of Mercury

Clinically Relevant Size

[?]

Size Type Text
Length: 34 Centimeter
Width: 23 Centimeter
Height: 3 Centimeter

Device Record Status

Public Device Record Key: e2204b22-06ef-4b15-9a1e-79816357e158
Public Version Date: May 21, 2021
Public Version Number: 1
DI Record Publish Date: May 13, 2021