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SURGIFOAM® Absorbable Gelatin Powder

Primary DI
15712123000240
Brand
SURGIFOAM® Absorbable Gelatin Powder
Company
Ferrosan Medical Devices A/S
Model
1978
Published
2014-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LMFAgent, Absorbable Hemostatic, Collagen Based

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMFAgent, Absorbable Hemostatic, Collagen BasedGeneral, Plastic Surgery3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P990004004
P990004013
P990004036
P990004039
P990004041
P990004042
P990004047
P990004049
P990004051
P990004052
P990004054
P990004056
P990004058
P990004065
P990004069
P990004070
P990004072

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P990004004SURGIFOAM ABSORBABLE GELATIN SPONGE, USPFerrosan Meidcal Devices A/S1999-09-30LMF
P990004013SURGIFOAM ABSORBABLE GELATIN SPONGE, USPFerrosan Meidcal Devices A/S1999-09-30LMF
P990004036SURGIFOAM ABSORBABLE GELATIN SPONGE, USPFerrosan Meidcal Devices A/S1999-09-30LMF
P990004039SURGIFOAM ABSORBABLE GELATIN SPONGE, USPFerrosan Meidcal Devices A/S1999-09-30LMF
P990004041SURGIFOAM ABSORBABLE GELATIN SPONGE, USPFerrosan Meidcal Devices A/S1999-09-30LMF
P990004042SURGIFOAM ABSORBABLE GELATIN SPONGE, USPFerrosan Meidcal Devices A/S1999-09-30LMF
P990004047SURGIFOAM ABSORBABLE GELATIN SPONGE, USPFerrosan Meidcal Devices A/S1999-09-30LMF
P990004049SURGIFOAM ABSORBABLE GELATIN SPONGE, USPFerrosan Meidcal Devices A/S1999-09-30LMF
P990004051SURGIFOAM ABSORBABLE GELATIN SPONGE, USPFerrosan Meidcal Devices A/S1999-09-30LMF
P990004052SURGIFOAM ABSORBABLE GELATIN SPONGE, USPFerrosan Meidcal Devices A/S1999-09-30LMF
P990004054SURGIFOAM ABSORBABLE GELATIN SPONGE, USPFerrosan Meidcal Devices A/S1999-09-30LMF
P990004056SURGIFOAM ABSORBABLE GELATIN SPONGE, USPFerrosan Meidcal Devices A/S1999-09-30LMF
P990004058SURGIFOAM ABSORBABLE GELATIN SPONGE, USPFerrosan Meidcal Devices A/S1999-09-30LMF
P990004065SURGIFOAM ABSORBABLE GELATIN SPONGE, USPFerrosan Meidcal Devices A/S1999-09-30LMF
P990004069SURGIFOAM ABSORBABLE GELATIN SPONGE, USPFerrosan Meidcal Devices A/S1999-09-30LMF
P990004070SURGIFOAM ABSORBABLE GELATIN SPONGE, USPFerrosan Meidcal Devices A/S1999-09-30LMF
P990004072SURGIFOAM ABSORBABLE GELATIN SPONGE, USPFerrosan Meidcal Devices A/S1999-09-30LMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
25712123000247PackageGS16In Commercial Distribution
15712123000240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2571212300024725712123000247
1571212300024015712123000240

GMDN Terms#

Term, Definition table
TermDefinition
Gelatin haemostatic agentA sterile, bioabsorbable device derived from animal gelatin (typically pork skin gelatin) that is intended to be applied to surgical and traumatic wounds to facilitate local haemostasis through its high blood-absorbing capacity; it does not contain an antimicrobial agent. It is typically in the form of a pad/sponge and has no intrinsic haemostatic action but induces haemostasis through its intensely porous structure which enables it to absorb many times its weight in blood; the device is intended to remain in the wound to be absorbed by the body. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight1Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
305175344
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15712123000141SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. Oral Sponge19692014-09-20
15712123000226SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. Hemorrhoidectomy Sponge19772014-09-20
15712123000158SURGIFOAM® Absorbable Gelatin Sponge, U.S.P.19722014-09-20
15712123000172SURGIFOAM® Absorbable Gelatin Sponge, U.S.P.19732014-09-20
15712123000189SURGIFOAM® Absorbable Gelatin Sponge, U.S.P.19742014-09-20
15712123000202SURGIFOAM® Absorbable Gelatin Sponge, U.S.P.19752014-09-20
15712123000646SURGIFLO™ Hemostatic Matrix Kit with ThrombinSF29952026-01-05
25712123000643SURGIFLO™ Hemostatic Matrix Kit with ThrombinSF29952026-01-05
15712123000288SURGIFLO® Hemostatic Matrix Kit with Thrombin29942016-05-10
15712123000318SURGIFLO® Hemostatic Matrix29912014-09-20
15712123000264SURGIFOAM® Absorbable Gelatin Powder Kit19792014-09-24
15712123000325SURGIFLO® Hemostatic Matrix Kit with Thrombin29932014-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15712123000646SURGIFLO™ Hemostatic Matrix Kit with ThrombinFerrosan Medical Devices A/SLMF2026-01-05
25712123000643SURGIFLO™ Hemostatic Matrix Kit with ThrombinFerrosan Medical Devices A/SLMF2026-01-05
00801741223105AviteneDavol Inc.LMF2023-06-27
10801741223102AviteneDavol Inc.LMF2023-06-27
10381780508656OraFOAM™Integra Lifesciences CorporationLMF2019-02-04
00300092250018GEL-FLOW KITPHARMACIA & UPJOHN COMPANY LLCLMF2018-08-17
00300091040016GEL-FLOW™ NTPHARMACIA & UPJOHN COMPANY LLCLMF2018-04-17
00300091040061GEL-FLOW™ NTPFIZER INC.LMF2018-04-17
00085412086309Gelfoam PlusBAXTER HEALTHCARE CORPORATIONLMF2017-12-21
50085412086304Gelfoam PlusBAXTER HEALTHCARE CORPORATIONLMF2017-12-21
00085412096100Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATIONLMF2017-10-09
00085412096124Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATIONLMF2017-10-09
50085412096105Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATIONLMF2017-10-09
00360793310107GELFOAM-JMI™ Sponge KitPHARMACIA & UPJOHN COMPANY LLCLMF2017-06-05
00360793410104GELFOAM-JMI™ Powder KitPHARMACIA & UPJOHN COMPANY LLCLMF2017-06-05
00085412095158Gelfoam PlusBAXTER HEALTHCARE CORPORATIONLMF2016-09-08
00085412095165Gelfoam PlusBAXTER HEALTHCARE CORPORATIONLMF2016-09-08
50085412095153Gelfoam PlusBAXTER HEALTHCARE CORPORATIONLMF2016-09-08
50085412095160Gelfoam PlusBAXTER HEALTHCARE CORPORATIONLMF2016-09-08
15712123000288SURGIFLO® Hemostatic Matrix Kit with ThrombinFerrosan Medical Devices A/SLMF2016-05-10
00085412096094Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATIONLMF2015-05-22
00085412096117Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATIONLMF2015-05-22
00085412091006Floseal Special Applicator TipsBAXTER HEALTHCARE CORPORATIONLMF2015-05-14
50085412091001Floseal Special Applicator TipsBAXTER HEALTHCARE CORPORATIONLMF2015-05-14
00808232000801VitagelStryker OrthobiologicsLMF2014-09-24
00808232000818VitagelStryker OrthobiologicsLMF2014-09-24
00808232001242VitaPrepStryker CorporationLMF2014-09-24
00808232001389VitagelStryker CorporationLMF2014-09-24
00808232001396VitagelStryker CorporationLMF2014-09-24
15712123000264SURGIFOAM® Absorbable Gelatin Powder KitFerrosan Medical Devices A/SLMF2014-09-24