AccessGUDID - DEVICE: V.A.T.S. BULLDOG APPLYING FORCEPS (B09921008290)

GUDID

Device Identifier (DI) Information

Brand Name: V.A.T.S. BULLDOG APPLYING FORCEPS
Version or Model: 2100-829
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: B09921008290
Issuing Agency: HIBCC
Commercial Distribution End Date: September 29, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: V.A.T.S. BULLDOG APPLYING FORCEPS WITH RATCHET ANGLED

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?
42468	Clamp manipulation forceps	A hand-held manual surgical instrument with a dedicated, slotted, working end that is designed to accept, grasp, open, apply and remove small types of bulldog/vascular clamps. It is typically made of high-grade stainless steel with jaws at the working end designed to accept the clamp; this gives the surgeon greater range of use of the bulldog clamp into the wound. It has typically a straight design with a slightly curved geometry toward the working end. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152400	000

Device Exempt from Premarket Submission: No 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: 13 Inch
Device Size Text, specify: 60° Jaw

Device Record Status

Public Device Record Key: c19fb593-6867-4405-b49b-186b77ab9f95
Public Version Date: October 01, 2018
Public Version Number: 7
DI Record Publish Date: August 19, 2016