FDA.reportPublic FDA data

Gelfoam

Primary DI
10300090433045
Brand
Gelfoam
Company
PHARMACIA & UPJOHN COMPANY LLC
Model
1 g Powder
Device description
Absorbable Hemostatic Powder, Collagen Based
Published
2014-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
N18286017
N18286018
N18286020
N18286021
N18286023
N18286024
N18286025
N18286026

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
N18286017GELFOAMPfizer, Inc.1983-07-08LMF
N18286018GELFOAMPfizer, Inc.1983-07-08LMF
N18286020GELFOAMPfizer, Inc.1983-07-08LMF
N18286021GELFOAMPfizer, Inc.1983-07-08LMF
N18286023GELFOAMPfizer, Inc.1983-07-08LMF
N18286024GELFOAMPfizer, Inc.1983-07-08LMF
N18286025GELFOAMPfizer, Inc.1983-07-08LMF
N18286026GELFOAMPfizer, Inc.1983-07-08LMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00300090433048PackageGS16In Commercial Distribution
10300090433045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00300090433048003000904330483000904330480300090433048
1030009043304510300090433045

GMDN Terms#

Term, Definition table
TermDefinition
Collagen haemostatic agent, non-antimicrobialA bioabsorbable device derived from animal collagen (e.g., bovine or porcine collagen) designed to produce a rapid haemostasis through platelet activation/aggregation (which initiates the haemostatic cascade leading to a fibrin clot) during a surgical procedure. It is applied directly to the wound where it remains to be absorbed by the body; it is not dedicated to a specific anatomy/application and does not contain an antimicrobial agent. It may be supplied as a fibrillar or soft, pliable pad/sponge or loose fibres; it may be applied in combination with fibrin adhesives. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Weight1Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00See USP Controlled Room Temperature
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(484)865-6166UDICompliance@pfizer.com

Regulatory Flags#

DUNS number
618054084
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10300132647034Genotropin Pen® 12F0000991112019-09-05
10300134761929Genotropin Pen® 5F0001161532019-09-05
00300090297015GelfilmGelfilm® Sterile Ophthalmic Film Ophthalmic film 62015-10-22
10300090283015GelfilmGelfilm® Sterile Film Sterile film 1's (125 sq cm)2016-05-11
00300090283018GelfilmGelfilm® Sterile Film Sterile film 1's (125 sq cm)2015-10-22
00300091040016GEL-FLOW™ NTHemostatic Matrix for Flowable Applications - 6 mL2018-04-17
00300092250018GEL-FLOW KIT6 mL2018-08-17
00360793310107GELFOAM-JMI™ Sponge KitSize 1002017-06-05
00360793410104GELFOAM-JMI™ Powder Kit1 g Powder2017-06-05
10300090315082GelfoamSize 12-72014-09-01
10300090323018GelfoamSize 502014-09-01
10300090342019GelfoamSize 1002014-09-01
10300090349032GelfoamSize 2002014-09-01
10300090353015GelfoamSize 100 - Compressed2014-09-01
10300090396050GelfoamSize 4, 2 sponges per envelope2014-09-01
00300093359017Prepidil® Gel, dinoprostone cervical gelNDC 0009-3359-012020-09-24
00300090315085GelfoamSize 12-72014-09-01
00300090323011GelfoamSize 502014-09-01
00300090342012GelfoamSize 1002014-09-01
00300090349035GelfoamSize 2002014-09-01

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