FDA.report

Sabo

Primary DI
07613154705078
Brand
Sabo
Company
STRYKER CORPORATION
Model
4300034000
Catalog number
4300-034-000
Device description
Sagittal Saw
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HRXARTHROSCOPE

Product Code Classifications

CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613154705078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613154705078076131547050787613154705078

GMDN Terms

TermDefinition
Rechargeable battery-powered surgical power tool system motorA compact engine that draws power from a rechargeable battery pack intended to convert electrical energy into a non-dedicated mechanical energy to perform a variety of surgical procedures that include drilling, sawing, and inserting involving bones and tough tissues (e.g., cartilage, ligaments). It is typically a pistol-like handpiece that connects to a variety of surgical power tool attachments. The device may be cannulated to permit use of a guidewire. It may be operated with a hand- or foot-switch; it is not intended to draw power from a line-powered control unit. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius40 Degrees Celsius

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
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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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04056702012076Patient tube for irrigation, single-useW.O.M. World of Medicine GmbHHRX2026-03-10
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