AccessGUDID - DEVICE: Hemagard (00384401014157)

GUDID

Device Identifier (DI) Information

Brand Name: Hemagard
Version or Model: HGK0008-70
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HGK0008-70
Company Name: INTERVASCULAR SAS

Primary DI Number: 00384401014157
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 382174019 *Terms of Use

Device Description: Hemagard Knitted Straight Collagen Coated Vascular Graft

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:	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?
35281	Synthetic vascular graft	An implantable artificial substitute for a blood vessel intended to replace or bypass a diseased or injured vessel, typically the aorta, an iliac, a femoral or popliteal artery; it is not intended for use in the coronary arteries. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics; it does not incorporate a metallic mesh (i.e., it is not a stent-graft).	Active	true

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 [?]
K964625	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: Room Temperature

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 8 Millimeter
Length: 70 Centimeter

Device Record Status

Public Device Record Key: eb49f3c7-ed82-46bd-b7be-e736bac22cc5
Public Version Date: September 24, 2025
Public Version Number: 6
DI Record Publish Date: September 24, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +33442084646
Email: cardiovascular.vics@getinge.com

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