FDA.reportPublic FDA data

NA

Primary DI
04546540169594
Brand
NA
Company
STRYKER CORPORATION
Model
0298097100
Catalog number
0298-097-100
Device description
Sternum Blade, Offset (32.0 x 0.8 x 6.3mm)
Published
2018-09-23
Public version status
Update
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
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
04546540169594PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540169594045465401695944546540169594

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
Depth6.3Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)253-3210Inst.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
07613327632811Maistro06200020000620-002-0002025-10-10
07613327060058Precision Ideal Eyes05028190100502-819-0102016-09-23
07613327623338AXS LiftLIFT074095-01LIFT074095-012025-03-04
07613327623352AXS LiftLIFT074105-01LIFT074105-012025-03-04
07613327623376AXS LiftLIFT074110-01LIFT074110-012025-03-04
07613327623390AXS LiftLIFT074115-01LIFT074115-012025-03-04
07613327060027Precision Ideal Eyes05028190300502-819-0302016-09-23
07613327060072Precision Ideal Eyes05028230300502-823-0302016-09-23
07613327060102Precision Ideal Eyes05028231300502-823-1302016-09-23
07613327060119Precision Ideal Eyes05028270100502-827-0102016-09-23
07613327060126Precision Ideal Eyes05028230700502-823-0702016-09-23
07613327060140Precision Ideal Eyes05028270700502-827-0702016-09-23
07613327060157Precision Ideal Eyes05028271300502-827-1302016-09-23
07613327060164Precision Ideal Eyes05028270300502-827-0302016-09-23
07613327060232Precision Ideal Eyes05028230100502-823-0102016-09-23
07613327063875Precision Ideal Eyes, Speed-Lock05029270100502-927-0102016-09-23
07613327063882Precision Ideal Eyes, Speed-Lock05029270300502-927-0302016-09-23
07613327063899Precision Ideal Eyes, Speed-Lock05029270700502-927-0702016-09-23
07613327681741N/A48110005481100052025-09-03
07613327681727N/A48110004481100042025-09-03

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