FDA.reportPublic FDA data

SURGIFLO® Hemostatic Matrix Kit with Thrombin

Primary DI
15712123000325
Brand
SURGIFLO® Hemostatic Matrix Kit with Thrombin
Company
Ferrosan Medical Devices A/S
Model
2993
Published
2014-09-20
Public version status
Update
Distribution status
Not 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
P990004008
P990004016
P990004017
P990004018
P990004019
P990004022

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P990004008SURGIFOAM ABSORBABLE GELATIN SPONGE, USPFerrosan Meidcal Devices A/S1999-09-30LMF
P990004016SURGIFOAM ABSORBABLE GELATIN SPONGE, USPFerrosan Meidcal Devices A/S1999-09-30LMF
P990004017SURGIFOAM ABSORBABLE GELATIN SPONGE, USPFerrosan Meidcal Devices A/S1999-09-30LMF
P990004018SURGIFOAM ABSORBABLE GELATIN SPONGE, USPFerrosan Meidcal Devices A/S1999-09-30LMF
P990004019SURGIFOAM ABSORBABLE GELATIN SPONGE, USPFerrosan Meidcal Devices A/S1999-09-30LMF
P990004022SURGIFOAM ABSORBABLE GELATIN SPONGE, USPFerrosan Meidcal Devices A/S1999-09-30LMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
25712123000322PackageGS16Not in Commercial Distribution
15712123000325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2571212300032225712123000322
1571212300032515712123000325

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit77 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
15712123000240SURGIFOAM® Absorbable Gelatin Powder19782014-09-20
15712123000264SURGIFOAM® Absorbable Gelatin Powder Kit19792014-09-24

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