AccessGUDID - DEVICE: Exacto (00724995182557)

GUDID

Device Identifier (DI) Information

Brand Name: Exacto
Version or Model: 00711094
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00711094
Company Name: US Endoscopy

Primary DI Number: 00724995182557
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 627879687 *Terms of Use

Device Description: The Exacto cold snare is intended to be used without diathermic energy for the endoscopic resection of polyp tissue in the gastrointestinal tract.

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?
62615	Mechanical-cutting endoscopic polypectomy snare	A sterile, flexible, non-powered (i.e., not electrosurgical) device intended to be inserted through an endoscope to ensnare and cut polyps or other mucosal lesions during endoscopic surgery. It typically consists of a flexible sheath with a sharp cutting snare loop attached to the distal end of the sheath, and a handle which mechanically controls snaring through manual action. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FGX	SNARE, NON-ELECTRICAL

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
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: ce173739-adb8-4c03-bf0a-a7f6685bbba7
Public Version Date: April 08, 2021
Public Version Number: 1
DI Record Publish Date: March 31, 2021