AccessGUDID - DEVICE: PuraStat (3mL) (00860001820874)

GUDID

Device Identifier (DI) Information

Brand Name: PuraStat (3mL)
Version or Model: 621-062
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 621-062
Company Name: 3-D MATRIX INC.

Primary DI Number: 00860001820874
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058207695 *Terms of Use

Device Description: PuraStat is a hemostat for mild and moderate bleeding intended to be used in gastrointestinal surgery (3 mL)

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?
47917	Non-organic haemostatic agent	A non-bioabsorbable device made of mineral and/or synthetic polymer components (e.g., smectite, potassium ferrate/hydrophilic polymer) intended for application to a bleeding external epithelial wound [i.e., skin wound or gastrointestinal (GI) mucosa wound] to facilitate local haemostasis through formation of a sealant and/or clot acceleration; it might additionally be intended to absorb bodily fluids. It is available in various forms (e.g., powder, gel, impregnated gauze) intended to be applied directly or endoscopically to the wound temporarily; it does not contain an antimicrobial agent. Disposable manual or electronic devices for application may be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QAU	Hemostatic Device For Endoscopic Gastrointestinal Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210098	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7ae55eca-ee84-4b9d-851e-3df27769c533
Public Version Date: September 05, 2023
Public Version Number: 1
DI Record Publish Date: August 28, 2023