AccessGUDID - DEVICE: GRAFT SIZERS (00384401016519)

GUDID

Device Identifier (DI) Information

Brand Name: GRAFT SIZERS
Version or Model: Size 24 mm - 38 mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INTERVASCULAR SAS

Primary DI Number: 00384401016519
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 382174019 *Terms of Use

Device Description: Graft Sizers size 24 mm - 38 mm are commercially available only in Multipack configuration (box of 10 units) with the catalog number M002363200211.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
44744	Open-surgery blood vessel sizer, single-use	A sterile, invasive instrument intended to be used during open vascular surgery to approximate the size of a blood vessel for selection of an appropriately sized vascular device/implant (e.g., vascular graft, emboli filter); it is not intended to obtain a precise measurement. The device typically consists of a C-shaped (half circle) sizing portion with a handle, sometimes available in a range of sizes, and is intended to size the outer diameter of the blood vessel (i.e., extraluminal sizing); it may in addition be used to size a vascular graft. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K854431	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
Special Storage Condition, Specify: Store at controlled room temperature

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 24 mm - 38 mm

Device Record Status

Public Device Record Key: 5dfa576c-00f8-498e-8431-494ac384a9b7
Public Version Date: April 04, 2023
Public Version Number: 4
DI Record Publish Date: June 24, 2016