AccessGUDID - DEVICE: InTrack® Inserts (00852621004086)

GUDID

Device Identifier (DI) Information

Brand Name: InTrack® Inserts
Version or Model: N-10127v
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N-10127v
Company Name: VITALITEC INTERNATIONAL, INC.

Primary DI Number: 00852621004086
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 121464288 *Terms of Use

Device Description: Supplied as a pair for use in jaws of resuable clamps.

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":	Yes
For Single-Use:	Yes
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?
34948	Artery clamp	A hand-held manual surgical instrument designed for the temporary, atraumatic compression of an artery for haemostasis (arrest or prevention of bleeding) during a procedure. It typically has a self-retaining, scissors-like design with ring handles and is made of high-grade stainless steel; it may utilize inserts made of various materials (e.g., carbide). It is available in various sizes and designs of the working end are specific to the surgical application. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DXC	Clamp, Vascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K992980	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0aca1cfc-7082-4d20-af4e-fae9127b4056
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 26, 2016