Home GUDID 00860007400308 PuraGel 3mL
Primary DI 00860007400308
Brand PuraGel 3mL
Company 3-D MATRIX INC.
Model 651-005
Catalog number 651-005
Device description PuraGel™ is a space-occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help to control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process. PuraGel™ is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate and formation of nasal adhesions during the post-operative period. PuraGel™ is also indicated to adhere to oral tissue and form a protective barrier over the wound to prevent irritation and contamination to manage the pain in all types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa. It provides a moist wound environment required for optimal wound healing. (3 ml)
Published 2023-09-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable OLR Oral Wound Dressing
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic Unknown U NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable Ear, Nose, Throat 2 OLR Oral Wound Dressing Unknown U
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860007400308 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860007400308 00860007400308 860007400308 0860007400308
GMDN Terms# Term, Definition table Term Definition 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 058207695 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00368040753141 Promiseb Topical Cream Primus Pharmaceuticals, Inc. MGQ 2026-05-01 04714691213958 VeraFill Dental Collagen Wound Dressing MAXIGEN BIOTECH INC. OLR 2026-03-30 04714691213934 VeraFill Dental Collagen Wound Dressing MAXIGEN BIOTECH INC. OLR 2025-11-04 00850058790114 RV-X1 Gel4med, Inc. MGQ 2025-10-17 00850058790121 RV-X1 Gel4med, Inc. MGQ 2025-10-17 00850058790138 G4Derm Plus Gel4med, Inc. MGQ 2025-10-17 00850058790145 G4Derm Plus Gel4med, Inc. MGQ 2025-10-17 00850058790152 G4Derm Plus Gel4med, Inc. MGQ 2025-10-17 04714691213903 HealiAid Dental Collagen Wound Dressing MAXIGEN BIOTECH INC. OLR 2025-09-30 04714691213910 HealiAid Dental Collagen Wound Dressing MAXIGEN BIOTECH INC. OLR 2025-09-30 04714691213897 HealiAid Dental Collagen Wound Dressing MAXIGEN BIOTECH INC. OLR 2025-09-22 04714691213859 HealiAid Dental Collagen Wound Dressing MAXIGEN BIOTECH INC. OLR 2025-06-12 00383160000104 Dash Topic AIM MEDICAL INC. MGQ 2025-05-12 00850058790060 Suprello Gel4med, Inc. MGQ 2025-03-25 00850058790084 Suprello Gel4med, Inc. MGQ 2025-03-25 00850058790091 Suprello Gel4med, Inc. MGQ 2025-03-25 04714691213705 Guide Plug Collagen Wound Dressing MAXIGEN BIOTECH INC. OLR 2025-03-13 04714691213712 Guide Plug Collagen Wound Dressing MAXIGEN BIOTECH INC. OLR 2025-03-13 04714691213682 Guide Plug Collagen Wound Dressing MAXIGEN BIOTECH INC. OLR 2025-03-13 04714691213699 Guide Plug Collagen Wound Dressing MAXIGEN BIOTECH INC. OLR 2025-03-13 00860013569907 MuGard Soleva Pharma LLC MGQ 2025-02-28 00860013569907 MuGard Soleva Pharma LLC OLR 2025-02-28 04714691213552 HealiAid Dental Collagen Wound Dressing MAXIGEN BIOTECH INC. OLR 2024-11-18 04714691213569 HealiAid Dental Collagen Wound Dressing MAXIGEN BIOTECH INC. OLR 2024-11-18 04714691213576 HealiAid Dental Collagen Wound Dressing MAXIGEN BIOTECH INC. OLR 2024-11-18 04714691850443 Curagen collagen wound dressing MAXIGEN BIOTECH INC. OLR 2024-11-18 04714691850450 Curagen collagen wound dressing MAXIGEN BIOTECH INC. OLR 2024-11-18 04714691213521 HealiAid Dental Collagen Wound Dressing MAXIGEN BIOTECH INC. OLR 2024-11-18 04714691213538 HealiAid Dental Collagen Wound Dressing MAXIGEN BIOTECH INC. OLR 2024-11-18 04714691213545 HealiAid Dental Collagen Wound Dressing MAXIGEN BIOTECH INC. OLR 2024-11-18