AccessGUDID - DEVICE: Colorectal Air Syringe-OP EX (00860002701318)

GUDID

Device Identifier (DI) Information

Brand Name: Colorectal Air Syringe-OP EX
Version or Model: ALT-30EX
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ALT-30EX
Company Name: TOOLS FOR SURGERY, LLC

Primary DI Number: 00860002701318
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 841842441 *Terms of Use

Device Description: Expedite and standardize the 'bubble test' for colorectal anastomoses. Includes 3 extender tips.

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?
35800	Endoscope inflation bulb	A device that is used in conjunction with an endoscope and its direct application and which assists in the use of the endoscope. It is a dedicated device shaped as a rubber bulb which is used to feed air via the endoscope to obtain an endoscopic view of the site. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCY	Bulb, Inflation, For Endoscope

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 8.5 Inch

Device Record Status

Public Device Record Key: 5271c269-2dba-4dd6-ae76-7d239526e9ea
Public Version Date: June 13, 2023
Public Version Number: 2
DI Record Publish Date: December 17, 2019