AccessGUDID - DEVICE: Endo-Boot (10724995184015)

GUDID

Device Identifier (DI) Information

Brand Name: Endo-Boot
Version or Model: 00711621
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00711621
Company Name: US Endoscopy

Primary DI Number: 10724995184015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 627879687 *Terms of Use
Previous DI: 10816765013417

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
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f0f0fec8-20ca-4bcb-819b-2fc1f6cd5443
Public Version Date: November 10, 2020
Public Version Number: 2
DI Record Publish Date: April 01, 2020