AccessGUDID - DEVICE: Evotech (10705037012497)

GUDID

Device Identifier (DI) Information

Brand Name: Evotech
Version or Model: 841902
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 841902
Company Name: ADVANCED STERILIZATION PRODUCTS SERVICES INC.

Primary DI Number: 10705037012497
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 947451626 *Terms of Use

Device Description: Connector Tube Yellow

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?
37090	Endoscope assembly adaptor	A connecting component of a flexible or rigid endoscope assembly intended to be used to join one or more endoscope elements to create a complete endoscope assembly, or to enable the connection of other devices (e.g., a laser). It may also be fitted with stop-cocks or instrument ports for the introduction of devices (e.g., catheters), fluids, gases, or to perform aspiration. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FEB	ACCESSORIES, CLEANING, FOR ENDOSCOPE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K082392	000
K140977	000

Device Exempt from Premarket Submission: No 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 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 223fd988-8f22-4676-a102-3579b3d3d440
Public Version Date: December 11, 2020
Public Version Number: 4
DI Record Publish Date: September 24, 2016