FDA.reportPublic FDA data

Vitagel

Primary DI
30808232000833
Brand
Vitagel
Company
Stryker Corporation
Model
2090-0036
Catalog number
2090-0036
Device description
Spray Set
Published
2016-09-24
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
FMFSyringe, piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052173000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052173000VITAGEL SURGICAL HEMOSTAT SPRAY SETOrthovita, Inc.2005-10-19FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30808232000833PrimaryGS10
00808232000832Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3080823200083330808232000833
00808232000832008082320008328082320008320808232000832

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate system delivery unitA mains electricity (AC-powered) device that is a component of a haematological concentrate system and used to deliver a processed haematological concentrate through tubing to a hand-held applicator (typically a spraypen or endoscopic applicator). Upon activation (e.g., via a foot-switch operated by surgical staff) it typically generates a low pressure for the delivery of the concentrate.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Dry and Ambient

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
149183167
Device count
5
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
00850024195028MOLLIMM10002021-08-27
00850024195134MOLLIMS-00009MM10122022-06-27
00850024195219MOLLIMP2015A2024-04-13
00850024195141MOLLIMP20012023-03-30
00850024195158MOLLIMT20012023-03-30
00850024195004MOLLIMP10012021-08-27
00850024195011MOLLIMT10012021-08-27
07613327651232SportSuite0203-10000203-10002026-08-21
07613327679410Mini-PRO Pediatric Restraint System (with Modified X-Restraints)6410055500016410055500012026-08-21
07613327170559VertaPlex HV04066220150406-622-0152016-09-23
07613327358308iVAS8080108000808-010-8002019-01-11
04546540434371PCD SpinePlex05055820000505-582-0002015-09-24
04546540434388PCD SpinePlex05055830000505-583-0002015-09-24
04546540434395PCD SpinePlex05055850000505-585-0002015-09-24
04546540434401PCD SpinePlex05055860000505-586-0002015-09-24
04546540434418PCD05055870000505-587-0002015-09-24
04546540434425PCD05055890000505-589-0002015-09-24
07613327639032Broadway SystemBRW8E100D-3PK01BRW8E100D-3PK012025-03-12
07613327639049Broadway SystemBRW8E105D-3PK01BRW8E105D-3PK012025-03-12
07613327623338AXS LiftLIFT074095-01LIFT074095-012025-03-04

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