AccessGUDID - DEVICE: PuraGel 1mL (00860007400315)

GUDID

Device Identifier (DI) Information

Brand Name: PuraGel 1mL
Version or Model: 651-004
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 651-004
Company Name: 3-D MATRIX INC.

Primary DI Number: 00860007400315
Issuing Agency: GS1
Commercial Distribution End Date: September 20, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 058207695 *Terms of Use

Device Description: PuraGel is a hemostat for mild and moderate bleeding intended to be used in a variety of indications. (1 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?
60919	Synthetic peptide haemostatic agent	A sterile, bioabsorbable device containing synthetic peptides intended to be applied to a surgical site to rapidly facilitate local haemostasis primarily through formation of a peptide hydrogel; it does not contain an antimicrobial agent. It is typically available as an aqueous solution (e.g., prefilled syringe) that can be applied directly to the wound where it remains to be absorbed by the body. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NHB	Polymer, Ear, Nose And Throat, Synthetic, Absorbable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K183015	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5312015f-c645-448a-a9e7-440ac0409f24
Public Version Date: September 28, 2023
Public Version Number: 1
DI Record Publish Date: September 20, 2023