AccessGUDID - DEVICE: ProArmor (00724995190637)

GUDID

Device Identifier (DI) Information

Brand Name: ProArmor
Version or Model: 00711623
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00711623
Company Name: US Endoscopy

Primary DI Number: 00724995190637
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 627879687 *Terms of Use

Device Description: ProArmor endoscope tip protector, sterile protects the distal tip of an endoscope and other surgical equipment.

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?
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: Yes
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: 10982ca2-0894-4754-9cb5-5f4cc725dd61
Public Version Date: November 10, 2020
Public Version Number: 2
DI Record Publish Date: July 16, 2020