FDA.reportPublic FDA data

Stryker Performance Series

Primary DI
37613154501145
Brand
Stryker Performance Series
Company
STRYKER CORPORATION
Model
6207097101S1
Catalog number
6207097101S1
Device description
Stryker Performance Series Sternum Blade
Published
2018-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWHBLADE, SAW, SURGICAL, CARDIOVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWHBlade, Saw, Surgical, CardiovascularGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613154501145PackageGS110In Commercial Distribution
07613154501144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761315450114537613154501145
07613154501144076131545011447613154501144

GMDN Terms#

Term, Definition table
TermDefinition
Sternum saw blade, single-useA sterile, flat metal surgical instrument, usually of a high-grade stainless steel quality, with a serrated edge designed for attachment to a dedicated powered surgical saw used for cutting the sternum (the breastbone) when a directional pressure is applied. This device is designed with a short blade and used during cardiovascular surgery. The cutting teeth are arranged in a straight line along the cutting edge and cut when the blade is powered in a rapid reciprocating movement (a back and forth motion like a jigsaw). The end of the blade is protected by a dedicated guide. This is a single-use device.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)253-3210Inst.Stryker.cs@Stryker.com

Regulatory Flags#

DUNS number
196548481
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
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
08809260475564TRAUSSaeshin Precision Co., Ltd.DWH2026-04-09
08809260475571TRAUSSaeshin Precision Co., Ltd.DWH2026-04-09
08809260475588TRAUSSaeshin Precision Co., Ltd.DWH2026-04-09
08809260475595TRAUSSaeshin Precision Co., Ltd.DWH2026-04-09
08809260475601TRAUSSaeshin Precision Co., Ltd.DWH2026-04-09
00887482085493Symmetry JacobsonASPEN SURGICAL PRODUCTS, INC.DWH2022-09-22
00887482073049Symmetry Wolff-BoehlerASPEN SURGICAL PRODUCTS, INC.DWH2022-09-16
00190776162993MillenniumAvalign Technologies, Inc.DWH2021-11-01
00190776163006MillenniumAvalign Technologies, Inc.DWH2021-11-01
00190776163013MillenniumAvalign Technologies, Inc.DWH2021-11-01
00190776163020MillenniumAvalign Technologies, Inc.DWH2021-11-01
17630055509472Short Microsaw Blade 22x0.4mmBien-Air Surgery SADWH2021-02-22
17630055509588Short Microsaw Blade 27x0.4mmBien-Air Surgery SADWH2021-02-22
17630055509595Short Microsaw Blade 32x0.4mmBien-Air Surgery SADWH2021-02-22
17630055509601Short Microsaw Blade 22x0.6mmBien-Air Surgery SADWH2021-02-22
17630055509618Short Microsaw Blade 27x0.6mmBien-Air Surgery SADWH2021-02-22
17630055509625Short Microsaw Blade 32x0.6mmBien-Air Surgery SADWH2021-02-22
17630055509632Long Microsaw Blade 22x0.4mmBien-Air Surgery SADWH2021-02-22
17630055509649Long Microsaw Blade 27x0.4mmBien-Air Surgery SADWH2021-02-22
17630055509656Long Microsaw Blade 32x0.4mm Bien-Air Surgery SADWH2021-02-22
17630055509663Long Microsaw Blade 22x0.6mmBien-Air Surgery SADWH2021-02-22
17630055509670Long Microsaw Blade 27x0.6mmBien-Air Surgery SADWH2021-02-22
17630055509687Long Microsaw Blade 32x0.6mmBien-Air Surgery SADWH2021-02-22
04046963091521AESCULAPAesculap AGDWH2020-05-08
04046963413675AESCULAPAesculap AGDWH2020-05-08
04046963839345AESCULAPAesculap AGDWH2020-05-08
07613153097709NASTRYKER CORPORATIONDWH2018-09-23
07613154501144Stryker Performance SeriesSTRYKER CORPORATIONDWH2018-09-23
04546540897923NASTRYKER CORPORATIONDWH2018-09-23
04546540042101NASTRYKER CORPORATIONDWH2018-09-23