AccessGUDID - DEVICE: V.A.T.S BLACK SUTURE CUTTER (B09924059450)

GUDID

Device Identifier (DI) Information

Brand Name: V.A.T.S BLACK SUTURE CUTTER
Version or Model: 2405-945
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: B09924059450
Issuing Agency: HIBCC
Commercial Distribution End Date: September 28, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: V.A.T.S BLACK SUTURE CUTTER

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?
16224	Suture cutter, reusable	A dedicated hand-held surgical instrument designed for cutting sutures. It will typically have a protected scalpel-like blade which may be fixed or have a scissors-like cutting action. 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: 11 Inch
Device Size Text, specify: 5mm Tip

Device Record Status

Public Device Record Key: d97651cb-6a88-4b8e-97c3-a0c10490d15b
Public Version Date: September 28, 2018
Public Version Number: 8
DI Record Publish Date: August 19, 2016