FDA.reportPublic FDA data

N/a

Primary DI
07613327502985
Brand
N/a
Company
STRYKER CORPORATION
Model
5400-800-000
Catalog number
5400-800-000
Device description
Bone Vac
Published
2020-06-12
Public version status
New
Distribution status
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
BYZTRAP, STERILE SPECIMEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYZTrap, Sterile SpecimenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613327502986PackageGS15In Commercial Distribution
07613327502985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332750298637613327502986
07613327502985076133275029857613327502985

GMDN Terms#

Term, Definition table
TermDefinition
Bone graft harvesting filterA sterile receptacle designed to collect morselized (cut/shredded into small pieces) bone and bone marrow typically obtained during an intramedullary procedure involving reaming, irrigation, and aspiration (suction). The filter is situated, with connection tubing, between the bone harvesting device (e.g., the orthopaedic reamer handpiece) and a suction system which creates vacuum to draw the graft into the filter where it is captured. The retrieved tissue is used for surgical procedures requiring bone graft (e.g., to facilitate bone fusion and/or fill bone defects). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius27 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+0018002533210Inst.Stryker.cs@Stryker.com

Regulatory Flags#

DUNS number
196548481
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327524475Optablate97000151009700-015-1002022-09-23
07613327638233Omnicurve10320150001032-015-0002024-09-03
00857037006075LATERALATSYS24LATSYS242020-01-14
00857037006037LATERALATSYS20LATSYS202020-01-08
07613327060058Precision Ideal Eyes05028190100502-819-0102016-09-23
07613327006223ARIA48755700487557002019-11-20
07613327006919ES2 SPINAL SYSTEM48280082482800822019-11-20
07613327006926ES2 SPINAL SYSTEM48280083482800832019-11-20
07613327006940ES2 SPINAL SYSTEM48280086482800862019-11-20
07613327006957ES2 SPINAL SYSTEM48280087482800872019-11-20
07613327007114ES2 SPINAL SYSTEM48280311482803112019-11-25
07613327007558XIA 348237078482370782019-11-25
07613327007565XIA 348237079482370792019-11-25
07613327067088ACCULIF8003578003572016-09-24
07613327067095ACCULIF8003478003472016-09-24
07613327114799XIA 4.5 EVOLUTION48138140481381402019-11-21
07613327114812XIA 4.5 EVOLUTION48138011R48138011R2019-11-20
07613327114843XIA 4.5 EVOLUTION48138011L48138011L2019-11-20
07613327114850XIA 4.5 EVOLUTION48138101481381012019-11-21
07613327114874ES2 SPINAL SYSTEM48280178482801782019-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970057554396CITECChangzhou Intl. Trade & Enterprises Cooperative Co., Ltd.BYZ2026-07-27
06975238205746CITECChangzhou Intl. Trade & Enterprises Cooperative Co., Ltd.BYZ2026-07-27
06970057578286Polyp TrapsJiangsu Vedkang Medical Science and Technology Co.,Ltd.BYZ2026-05-22
00861092002613CeaLogic Specimen Collection KitRECIBIO, INC.BYZ2026-03-01
04260647240382OsteoPointMorpheus AGBYZ2024-11-26
06975238202561CITECChangzhou Intl. Trade & Enterprises Cooperative Co., Ltd.BYZ2024-07-12
10192253024449ArgyleCardinal Health 200, LLCBYZ2024-02-14
50192253024447ArgyleCardinal Health 200, LLCBYZ2024-02-14
00852360007027Tobra Graft CompressorTobra Medical, Inc.BYZ2023-05-18
10852360007024Tobra Graft CompressorTobra Medical, Inc.BYZ2023-05-18
00852360007003Tobra Bone BasketTobra Medical, Inc.BYZ2023-05-15
10852360007000Tobra Bone BasketTobra Medical, Inc.BYZ2023-05-15
B325FM991Environ-mateM D Technologies Inc.BYZ2022-08-05
B325PT20101Environ-mateM D Technologies Inc.BYZ2022-08-05
B325PT20C101Environ-mateM D Technologies Inc.BYZ2022-08-05
B325FM990Environ-mateM D Technologies Inc.BYZ2022-08-05
B325PT20252Environ-mateM D Technologies Inc.BYZ2022-08-05
B325PT20C100Environ-mateM D Technologies Inc.BYZ2022-08-05
00860006413903Bone dust trapRIM Medical Technologies IncorporatedBYZ2022-07-10
04260647240139PHANTOM BONE COLLECTOR, SINGLE-USE, STERILEMorpheus AGBYZ2022-06-28
04260647240122Rebellion Tissue TrapMorpheus AGBYZ2022-06-27
10885632120343MedichoiceOWENS & MINOR DISTRIBUTION, INC.BYZ2021-06-10
50885632120341MedichoiceOWENS & MINOR DISTRIBUTION, INC.BYZ2021-06-10
10885632120336MediChoiceOWENS & MINOR DISTRIBUTION, INC.BYZ2021-06-08
50885632120334MediChoiceOWENS & MINOR DISTRIBUTION, INC.BYZ2021-06-08
00840117310377Resp-O2 Mucus Specimen Trap, Leak Proof Transport Cap, 40 ccDynarex CorporationBYZ2021-04-22
00840117310384Mucus Specimen TrapDYNAREX CORPORATIONBYZ2021-04-22
10080196818624MedlineMEDLINE INDUSTRIES, INC.BYZ2021-03-31
10080196999231MedlineMEDLINE INDUSTRIES, INC.BYZ2021-03-31
40080196818625MedlineMEDLINE INDUSTRIES, INC.BYZ2021-03-31