AccessGUDID - DEVICE: V.A.T.S BLACK SUTURE CUTTER (00192896004450)

GUDID

Device Identifier (DI) Information

Brand Name: V.A.T.S BLACK SUTURE CUTTER
Version or Model: 2405-945
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896004450
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use
Previous DI: B09924059450

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 [?]
Moist Heat or Steam Sterilization
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 5mm Tip
Length: 11 Inch

Device Record Status

Public Device Record Key: 9d580edd-df96-467b-95b9-8535eee68fb8
Public Version Date: September 28, 2018
Public Version Number: 1
DI Record Publish Date: August 28, 2018