FDA.reportPublic FDA data

NA

Primary DI
04546540042101
Brand
NA
Company
STRYKER CORPORATION
Model
2108137000
Catalog number
2108-137-000
Device description
2108 Series Sagittal Blade Sternum Revision (80.0 x 0.64 x 28.5mm)
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
04546540042101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540042101045465400421014546540042101

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
Depth28.5Millimeter
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
07613327652703N/A72000152707200-015-2702026-04-15
07613327652710PROstep72000150437200-015-0432026-04-13
07613327652727N/A72010157107201-015-7102026-04-13
07613327652734N/A72000153707200-015-3702026-04-13
07613154599127NA59200002045920-000-2042018-09-24
07613327413281Connected OR Hub02402001000240-200-1002023-07-26
07613327051674AIM SafeLight02330503000233-050-3002016-09-23
07613327056167SDC3024006010102400601012016-09-23
07613327056174SDC3024006010202400601022016-09-23
07613327382389168816880201221688-020-1222019-01-17
07613327405910Precision IE 4K0502-444-0700502-444-0702019-01-21
07613327405927Precision IE 4K0502-445-0300502-445-0302019-01-21
07613327405934Precision IE 4K0502-444-0100502-444-0102019-01-21
07613327405941Precision IE 4K0502-445-0700502-445-0702019-01-21
07613327405958Precision IE 4K0502-444-0300502-444-0302019-01-21
07613327405965Precision IE 4K0502-445-0100502-445-0102019-01-21
07613327405972Precision IE 4K0502-444-0450502-444-0452019-01-21
07613327405989Precision IE 4K0502-444-1300502-444-1302019-01-21
07613327416299Precision IE 4K0502-194-0100502-194-0102019-01-21
07613327416305Precision IE 4K0502-194-0300502-194-0302019-01-21

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
04546540169594NASTRYKER CORPORATIONDWH2018-09-23