FDA.report

NA

Primary DI
07613153089674
Brand
NA
Company
STRYKER CORPORATION
Model
0298097100S1
Catalog number
0298097100S1
Device description
Sternum Blade (31.1 x 0.79mm)
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

Related Records

Contact Domains

Product Codes

CodeName
DWHBLADE, SAW, SURGICAL, CARDIOVASCULAR

Product Code Classifications

CodeDeviceSpecialtyClass
DWHBlade, Saw, Surgical, CardiovascularGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613153089674PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613153089674076131530896747613153089674

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

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