FDA.report

3M™ Promogran™

Primary DI
04054596957879
Brand
3M™ Promogran™
Company
3M Deutschland GmbH
Model
PG019
Catalog number
PG019
Device description
3M™ Promogran™ Collagen Matrix with ORC, PG019, Hexagon 123 cm2 (19.1 sq in), 10/Ct, 4 Cts/Cs
Published
2023-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FRODressing, wound, drug

Product Code Classifications

CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04054596957879PackageGS14In Commercial Distribution
04054596957862PrimaryGS10
04054596957855Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04054596957879040545969578794054596957879
04054596957862040545969578624054596957862
04054596957855040545969578554054596957855

GMDN Terms

TermDefinition
Collagen wound matrix dressingA sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)634-22493Mhealthcarecompliance@mmm.com

Regulatory Flags

DUNS number
315731711
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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