AccessGUDID - DEVICE: Endo-Boot (10816765013417)

GUDID

Device Identifier (DI) Information

Brand Name: Endo-Boot
Version or Model: 00711621
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00711621
Company Name: US Endoscopy

Primary DI Number: 10816765013417
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2020
Device Count: 25
Labeler D-U-N-S® Number*: 627879687 *Terms of Use

Device Description: The Endo-Boot tip protector is used as a protective cover for the tip of the endoscope or other surgical instruments during storage and transport.

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":	Yes
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?
46505	Surgical instrument guard, single-use, sterile	A sterile device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during a procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
OCU	Endoscopic storage cover

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: 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 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fe245673-f736-4d84-a0b7-fe0afdeb98fa
Public Version Date: March 31, 2020
Public Version Number: 5
DI Record Publish Date: September 17, 2016