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
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

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