FDA.reportPublic FDA data

PROMOGRAN®

Primary DI
25051978003080
Brand
PROMOGRAN®
Company
SYSTAGENIX WOUND MANAGEMENT, LIMITED
Model
PG004
Catalog number
PG004
Device description
Matrix Wound Dressing
Published
2019-09-24
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

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
25051978003080PackageGS110In Commercial Distribution
15051978003083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2505197800308025051978003080
1505197800308315051978003083

GMDN Terms#

Term, Definition table
TermDefinition
Biochemically-interactive dressingA sterile, wound-covering substance or material (e.g., ointment, collagen matrix) intended to actively promote the healing of a wound through the temporary modification of a local biochemical parameter(s) or process(es) [e.g., a change to wound pH, enzymatic activity, or protein binding activity]. The device may be used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, or surgical wounds. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area28Square centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
211352227
Device count
1
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15051978001089FIBRACOL® PLUS298129812019-09-24
15051978001096FIBRACOL® PLUS298229822019-09-24
15051978001102FIBRACOL® PLUS298329832019-09-24
15051978001119FIBRACOL® PLUS298429842019-09-24
15051978002833PROMOGRAN PRISMA®MA028MA0282019-09-24
15051978002888PROMOGRAN PRISMA®MA123MA1232019-09-24
15051978003083PROMOGRAN®PG004PG0042019-09-24
15051978003090PROMOGRAN®PG019PG0192019-09-24
15051978009993PROMOGRAN PRISMA®MA032MA0322019-09-24
15051978003427DYNA-FLEX™70252018-09-24
15051978006428BIOCLUSIVE® PLUSBIP0607BIP06072019-09-24
15051978006435BIOCLUSIVE® PLUSBIP1012BIP10122019-09-24
15051978006442BIOCLUSIVE® PLUSBIP1520BIP15202019-09-24
15051978006459BIOCLUSIVE® PLUSBIP2030BIP20302019-09-24
15051978002543NU-DERM® HCB102HCB1022019-09-24
15051978002550NU-DERM® HCB106HCB1062019-09-24
15051978002567NU-DERM® HCS100HCS1002019-09-24
15051978002574NU-DERM®HCT101HCT1012019-09-24
15051978002581NU-DERM® HCB108HCB1082019-09-24
15051978002604NU-DERM® HCB204HCB2042019-09-24

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Primary DI, Brand, Company table
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05059884011201Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011218Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011225Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
00841277111378Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111385Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111392Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111408Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111382Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111405Novera SeamHarps USA, Inc.FRO2026-10-14
00050428034712CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428034743CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428142349CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428341728CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
10885380214813DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214820DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214837DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214844DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214851DermaceaCardinal Health 200, LLCFRO2026-10-09
06977727072259Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072266Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072273Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072280Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072457SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072464SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072471SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08