AccessGUDID - DEVICE: VORSE TUBE OCCLUDING CLAMP (B09911756820)

GUDID

Device Identifier (DI) Information

Brand Name: VORSE TUBE OCCLUDING CLAMP
Version or Model: 117-5682
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: B09911756820
Issuing Agency: HIBCC
Commercial Distribution End Date: July 18, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: VORSE TUBE OCCLUDING CLAMP NON SERRATED JAW WITH U GUARD 7.25 INCHES

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?
32146	Medical tubing clip/clamp, temporary, non-calibrated, reusable	A non-sterile, manual device designed to compress a piece of medical device tubing or tubular container to reversibly occlude its lumen and stop the flow of material within; it is not intended for patient-contact. It has a manual mechanism (e.g., hinging, roller-type, vice-like) whereby pressure on the tube can be applied or removed, however it is not a calibrated device (e.g., it is often a roller type, clip, or screw-clamp). It may be referred to as a clip or a clamp. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDJ	Clamp, Surgical, General & Plastic Surgery

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 [?]
Dry Heat Sterilization
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 7.25 Inch

Device Record Status

Public Device Record Key: 35755341-073e-45fe-b00c-30691f33dd9a
Public Version Date: July 19, 2023
Public Version Number: 7
DI Record Publish Date: October 21, 2016