AccessGUDID - DEVICE: D-Stat® Clamp topical hemostat accessory (M20630300)

GUDID

Device Identifier (DI) Information

Brand Name: D-Stat® Clamp topical hemostat accessory
Version or Model: 3030
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Vascular Solutions, Inc.

Primary DI Number: M20630300
Issuing Agency: HIBCC
Commercial Distribution End Date:
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:	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?
38031	Femoral artery compression pad	A sterile medicated device designed to provide compression for haemostasis to the puncture site on a patient having undergone femoral artery catheterization. It can be used as an alternative to direct hand pressure. It consists of a lyophilized pad containing various substances/pharmaceuticals (e.g., thrombin, sodium carboxymethylcellulose, and calcium chloride) with a plastic base and may be used alone or in conjunction with other devices, e.g., held in place with a bandage, belt or straps secured around the patient's hips/thigh. It is typically used following arterial/venous puncture, coronary angiography/ventriculography, and valvuloplasty. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DXC	Clamp, Vascular

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: b9a2f168-19a1-428a-bde7-2602180b499c
Public Version Date: November 11, 2019
Public Version Number: 4
DI Record Publish Date: September 15, 2016