AccessGUDID - DEVICE: OVERHOLD CLAMP INSERT (B09929012630)

GUDID

Device Identifier (DI) Information

Brand Name: OVERHOLD CLAMP INSERT
Version or Model: 2901-263
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: B09929012630
Issuing Agency: HIBCC
Commercial Distribution End Date: June 22, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: OVERHOLD CLAMP WITH FINE TEETH CURVED DOUBLE-ACTION JAW FOR TUBE SHAFT

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?
46374	Vascular Doppler clamp	An instrument with an integrated ultrasound transducer used for the detection and temporary occlusion of blood vessels during a surgical procedure. It is typically a held-hand device that is placed on the vasculature to be affected. It is connected to an appropriate signal receiver, and using the Doppler effect (variation in the frequency of a wave of energy (as measured by an observer) due to relative motion between the observer and the source of the wave), will provide the user with information regarding achieved occlusion of the vessel(s). It is typically used on uterine arteries during laparoscopic myomectomy. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002877	000

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
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 360 Millimeter
Device Size Text, specify: 10mm Shaft

Device Record Status

Public Device Record Key: e9a35865-dfba-4e7a-a313-e25e9ee13ac2
Public Version Date: July 06, 2018
Public Version Number: 7
DI Record Publish Date: August 19, 2016