FDA.reportPublic FDA data

NA

Primary DI
04546540730817
Brand
NA
Company
STRYKER CORPORATION
Model
0298097101S5
Catalog number
0298097101S5
Device description
Sternum Blade (45.9 x 0.635mm)
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
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
04546540730817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540730817045465407308174546540730817

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

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327687637N/A65170400166517-040-0162026-03-19
07613327687644N/A65170400106517-040-0102026-03-19
07613327687651N/A65170700216517-070-0212026-03-19
07613327687668N/A65170480216517-048-0212026-03-19
07613327687675N/A65170400126517-040-0122026-03-19
07613327628357RPS88080000008808-000-0002025-10-01
07613327656763BPX79000120007900-012-0002026-03-04
07613327656770BPX79000130007900-013-0002026-03-04
07613327657760BPX79000340007900-034-0002026-03-04
07613327657777BPX79000150007900-015-0002026-03-04
07613327657784BPX79000310007900-031-0002026-03-04
07613327657791BPX79000990007900-099-0002026-03-04
07613327657807N/A79003760107900-376-0102026-03-04
07613327657814BPX79000370007900-037-0002026-03-04
07613327657821N/A79003770107900-377-0102026-03-04
07613327657838N/A79003780107900-378-0102026-03-04
07613327659429BPX79000250007900-025-0002026-03-04
37613327693288Malis6760-180-0106760-180-010-Z012026-02-25
37613327693295Malis6760-180-0056760-180-005-Z012026-02-25
37613327693363Malis6760-180-0156760-180-015-Z012026-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887482085493Symmetry Surgical®SYMMETRY SURGICAL INC.DWH2022-09-22
00887482073049Symmetry Surgical®SYMMETRY SURGICAL 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 17x0.4mm Bien-Air Surgery SADWH2021-02-22
17630055509588Short microsaw blade 21x0.4mm Bien-Air Surgery SADWH2021-02-22
17630055509595Short microsaw blade 25x0.4mm Bien-Air Surgery SADWH2021-02-22
17630055509601Short microsaw blade 17x0.6mm Bien-Air Surgery SADWH2021-02-22
17630055509618Short microsaw blade 21x0.6mm Bien-Air Surgery SADWH2021-02-22
17630055509625Short microsaw blade 25x0.6mm Bien-Air Surgery SADWH2021-02-22
17630055509632Long microsaw blade 17x0.4mm Bien-Air Surgery SADWH2021-02-22
17630055509649Long microsaw blade 21x0,4mm Bien-Air Surgery SADWH2021-02-22
17630055509656Long microsaw blade 25x0,4mm Bien-Air Surgery SADWH2021-02-22
17630055509663Long microsaw blade 17x0,6mm Bien-Air Surgery SADWH2021-02-22
17630055509670Long microsaw blade 21x0,6mm Bien-Air Surgery SADWH2021-02-22
17630055509687Long microsaw blade 25x0,6mm Bien-Air Surgery SADWH2021-02-22
04046963091521AESCULAPAesculap AGDWH2020-05-08
04046963413675AESCULAPAesculap AGDWH2020-05-08
04046963839345AESCULAPAesculap AGDWH2020-05-08
04546540042101NASTRYKER CORPORATIONDWH2018-09-23
04546540169594NASTRYKER CORPORATIONDWH2018-09-23
04546540169600NASTRYKER CORPORATIONDWH2018-09-23
04546540730824Stryker Performance SeriesSTRYKER CORPORATIONDWH2018-09-23
04546540895042NASTRYKER CORPORATIONDWH2018-09-23
34546540897924NASTRYKER CORPORATIONDWH2018-09-23
04546540984425NASTRYKER CORPORATIONDWH2018-09-23
07613153004219NASTRYKER CORPORATIONDWH2018-09-23
07613153004233NASTRYKER CORPORATIONDWH2018-09-23