AccessGUDID - DEVICE: D-Stat® Radial topical hemostat (M20635010)

GUDID

Device Identifier (DI) Information

Brand Name: D-Stat® Radial topical hemostat
Version or Model: 3501
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Vascular Solutions, Inc.

Primary DI Number: M20635010
Issuing Agency: HIBCC
Commercial Distribution End Date: May 26, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 008999906 *Terms of Use

Device Description: No description.

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:	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?
64781	Thrombin haemostatic agent, non-antimicrobial	A non-bioabsorbable device containing animal-derived thrombin, without an antimicrobial agent, intended to be used by a healthcare professional for topical application to a surgical wound (e.g., during percutaneous vascular access), to facilitate local haemostasis primarily through thrombin activation of blood clotting mechanisms. It is typically available in the form of bandage, pad, or sponge that can be applied directly to the wound. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QSX	Hemostatic Wound Dressing With Thrombin Or Other Biologics

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 53467ba0-4b48-4997-8543-1edf4fac0f75
Public Version Date: June 06, 2023
Public Version Number: 5
DI Record Publish Date: September 15, 2016