FDA.reportPublic FDA data

Vitagel

Primary DI
00808232000818
Brand
Vitagel
Company
Stryker Orthobiologics
Model
2113-0003
Catalog number
2113-0003
Device description
Laparoscopic Extended 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
P050044000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P050044000VITAGEL RT3 SUTGICAL HEMOSTATStryker Corp.2006-06-16PMX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30808232000819PackageGS110Not in Commercial Distribution
00808232000818PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3080823200081930808232000819
00808232000818008082320008188082320008180808232000818

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
Special Storage Condition, Specify00Dry and Ambient

Contacts#

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

Regulatory Flags#

DUNS number
849227939
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00808232000801Vitagel2113-00022113-00022014-09-24
07613327064773Vitoss BA Injectable2102-23012102-23012017-07-12
07613327064780Vitoss BA Injectable2102-23022102-23022017-07-12
07613327064797Vitoss BA Injectable2102-23052102-23052017-07-12
30808232000802Vitagel2113-00022113-00022014-09-24
30808232000819Vitagel2113-00032113-00032014-09-24

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
00808232001242VitaPrepStryker CorporationLMF2014-09-24
00808232001389VitagelStryker CorporationLMF2014-09-24
00808232001396VitagelStryker CorporationLMF2014-09-24
15712123000264SURGIFOAM® Absorbable Gelatin Powder KitFerrosan Medical Devices A/SLMF2014-09-24
30808232000802VitagelStryker OrthobiologicsLMF2014-09-24