AccessGUDID - DEVICE: Circular Stapler Head Sizer Set (00860002701394)

GUDID

Device Identifier (DI) Information

Brand Name: Circular Stapler Head Sizer Set
Version or Model: HSS-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HSS-10
Company Name: TOOLS FOR SURGERY, LLC

Primary DI Number: 00860002701394
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 841842441 *Terms of Use

Device Description: Circular Stapler Head Sizer Set includes (1) 25 mm, (1) 29 mm, and (1) 33 mm reusable head sizers that are used to assist in choosing surgical stapler size.

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):	No
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?
58016	Colorectal sizer	A hand-held manual surgical instrument designed to assess colon and/or rectal lumen diameter to aid the selection of an appropriate size intraluminal stapler (i. e, the stapler head) for bowel anastomosis following transection. It is typically made of high-grade stainless steel and consists of a shaft handle at the proximal end and an oval-shaped head at the distal end that is introduced transanally. The device is typically available in a set of graduated sizes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOA	Surgical Instruments, G-U, Manual (And Accessories)

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: 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
Outer Diameter: 25 Millimeter
Outer Diameter: 29 Millimeter
Outer Diameter: 33 Millimeter

Device Record Status

Public Device Record Key: a4f40947-6265-46d9-9f7a-acca40d869aa
Public Version Date: July 27, 2023
Public Version Number: 1
DI Record Publish Date: July 19, 2023