FDA.reportPublic FDA data

Vitagel

Primary DI
00808232001389
Brand
Vitagel
Company
Stryker Corporation
Model
2113-0211
Catalog number
2113-0211
Device description
RT3 REACH9 Malleable Applicator
Published
2014-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
P050044028

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P050044028VITAGEL RT3 SUTGICAL HEMOSTATStryker Corp.2006-06-16PMX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30808232001380PackageGS15Not in Commercial Distribution
00808232001389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3080823200138030808232001380
00808232001389008082320013898082320013890808232001389

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate/haemostatic agent applicatorA hand-held, manually-operated device designed to administer, in a liquid or spray form, a haematological concentrate and/or haemostatic agent (e.g., thrombin, platelet concentrate, plant polysaccharide) to a surgical wound, lesion, or graft during surgery (open and/or endoscopic), typically to facilitate haemostasis and healing. It is typically a syringe-/plunger-like, single-channel or dual-channel (for co-administration of two separate agents) device, which may also be designed for connection to a gas pump for spraying. Delivery cannula(s)/tip(s) may be included. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(610)640-1775obxsharedservices@stryker.com

Regulatory Flags#

DUNS number
149183167
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327507935Stroke Fast PackSFP913140SFP9131402020-06-30
07613327507942Stroke Fast PackSFP913150SFP9131502020-06-30
07613327507959Stroke Fast PackSFP913160SFP9131602020-06-30
07613327507966Stroke Fast PackSFP913170SFP9131702020-06-30
07613327507973Stroke Fast PackSFP913180SFP9131802020-06-30
07613327507980Stroke Fast PackSFP913190SFP9131902020-06-30
07613327507997Stroke Fast PackSFP913100SFP9131002020-06-30
07613327635096InZone ISTIST345100960IST3451009602026-07-08
07613327638233Omnicurve10320150001032-015-0002024-09-03
07613327554724Omnicurve1033-130-0001033-130-0002023-11-07
07613327554687Omnicurve1033-115-0001033-115-0002022-04-12
07613327554700Omnicurve1033-120-0001033-120-0002022-04-12
07613327638226Omnicurve10330150001033-015-0002024-09-03
07613327638240Omnicurve10320200001032-020-0002024-09-03
07613327638257Omnicurve10330300001033-030-0002024-09-03
07613327638431Omnicurve10330200001033-020-0002024-09-03
07613327638448Omnicurve10320300001032-030-0002024-09-03
07613327554649Omnicurve1032-130-0001032-130-0002023-11-02
07613327413281Connected OR Hub02402001000240-200-1002023-07-26
07613327554663Omnicurve1032-120-0001032-120-0002022-04-12

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
00808232001396VitagelStryker CorporationLMF2014-09-24
15712123000264SURGIFOAM® Absorbable Gelatin Powder KitFerrosan Medical Devices A/SLMF2014-09-24
30808232000802VitagelStryker OrthobiologicsLMF2014-09-24