AccessGUDID - DEVICE: Hemashield (00384401017639)

GUDID

Device Identifier (DI) Information

Brand Name: Hemashield
Version or Model: M002020952120
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M002020952120
Company Name: INTERVASCULAR SAS

Primary DI Number: 00384401017639
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 382174019 *Terms of Use

Device Description: Hemashield Gold Knitted Microvel Straight Double Velour Vascular Graft with Graft Sizer Accessory

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:	Yes
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?
35281	Synthetic vascular graft	An implantable artificial substitute for a blood vessel intended to replace or bypass the diseased or injured vessel. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics and is best suited for large (more than 10 mm) diameter, high-flow vessel replacement (e.g., aortic or aorto-iliac artery reconstruction) and also for haemodialysis access and extra-anatomic bypass grafting. The device is used in many vascular bypass procedures (e.g., aorto-iliac, femoral-popliteal, axillo-axillary artery) except those involving the coronary arteries.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MAL	Graft, Vascular, Synthetic/Biologic Composite

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K954848	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: Controlled Room Temperature

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 12 Millimeter
Length: 60 Centimeter

Device Record Status

Public Device Record Key: b9c0d6c1-08b5-4c2e-817c-cac1b7b0d684
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: November 12, 2015