AccessGUDID - DEVICE: ValuTrus (20705036014529)

GUDID

Device Identifier (DI) Information

Brand Name: ValuTrus
Version or Model: ADCH
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ADCH
Company Name: ETHICON ENDO-SURGERY, LLC

Primary DI Number: 20705036014529
Issuing Agency: GS1
Commercial Distribution End Date: August 05, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 044606982 *Terms of Use

Device Description: ValuTrus Reusable Circular Stapler Handle

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:	No
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?
61622	Intraluminal circular stapler, reusable	A hand-held, manual surgical instrument intended to be used during open or laparoscopic surgical procedures of the alimentary tract, to create anastomoses (e.g., end-to-end, end-to-side, or side-to-side) via intraluminal (within the lumen) resection. It is designed to connect two portions of lumen (e.g., colon) with a single or multiple circular rows of staples, and then cut out the tissue within the staple line to create a new channel. This device operates via a manual lever mechanism and may be available in a variety of sizes appropriate to a specific luminal diameter. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDW	STAPLE, IMPLANTABLE

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 873c70a3-a7ce-47e2-a4ed-e1e9af581877
Public Version Date: August 06, 2021
Public Version Number: 3
DI Record Publish Date: August 24, 2015