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
CodeName
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
NHBPolymer, Ear, Nose And Throat, Synthetic, Absorbable
OLROral Wound Dressing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUnknownU
NHBPolymer, Ear, Nose And Throat, Synthetic, AbsorbableEar, Nose, Throat2
OLROral Wound DressingUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183015000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183015000PuraSinus3-D Matrix, Inc.2019-04-12NHB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860007400308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007400308008600074003088600074003080860007400308

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic peptide haemostatic agentA 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
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058207695
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860001820898PuraGel 5mL651-006651-0062023-09-20
00860007400315PuraGel 1mL651-004651-0042023-09-20
00860001820867PuraStat (1mL)621-061621-0612023-08-28
00860001820874PuraStat (3mL)621-062621-0622023-08-28
00860001820829PuraSinus 5mL651-0092022-07-13
00860001820836PuraSinus 3mL651-0082022-07-13
00860001820843PuraSinus 1mL651-007651-0072022-07-13

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