FDA.reportPublic FDA data

CORE, Maestro

Primary DI
34546540469107
Brand
CORE, Maestro
Company
STRYKER CORPORATION
Model
5400006000
Catalog number
5400006000
Device description
Diffuser
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBBMOTOR, DRILL, PNEUMATIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBBMotor, Drill, PneumaticNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34546540469107PackageGS110In Commercial Distribution
04546540469106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3454654046910734546540469107
04546540469106045465404691064546540469106

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical power tool system, pneumaticAn assembly of devices designed to resect bones and tough tissues (e.g., cartilage, ligaments) during a surgical procedure; it is not dedicated to a specific clinical application. It includes a pneumatically-powered control unit which controls output of nitrogen (N2) or surgical-grade air via a connecting hose, motors/handpieces/power tool attachments, and a variety of tools (e.g., drill bits, saw blades, burs, milling cutters, shavers, screwdriver bits, guide wires).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613252450337ICONIX3910-500-5123910-500-5122015-08-26
07613252450344ICONIX3910-500-5223910-500-5222015-08-26
07613252450351ICONIX3910-500-5253910-500-5252015-08-26
07613252450368ICONIX3910-500-5323910-500-5322015-08-26
07613327176926ICONIX39105003123910-500-3122015-09-14
07613327176933ICONIX39105003223910-500-3222015-09-14
07613327283440ICONIX39105002123910-500-2122016-09-22
07613327298642Sonopet iQ55000083005500-008-3002019-05-03
07613327056952SERFAS Energy0279351100279-351-1002016-09-23
07613327056976SERFAS Energy0279351103279-351-1032016-09-23
07613327057027SERFAS Energy0279401100279-401-1002016-09-23
07613327057034SERFAS Energy02794012000279-401-2002016-09-23
07613327057041SERFAS Energy02793514000279-351-4002016-09-23
07613327058048CrossFlow045000000004500000002016-09-23
07613327294606NanoTackCAT02969CAT029692016-07-20
07613327643800NA79000620007900-062-0002025-12-19
07613327643824NA79001260007900-126-0002025-12-19
07613327643848NA79001250007900-125-0002025-12-19
00897146002025Adherus NUS-109NUS-1092016-12-19
00897146002018Adherus NUS-106NUS-1062015-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251388960530VELOCITY ALPHA ™adeor Medical AGHBB2026-03-31
04251388910801VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388924105VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388959954VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388959961VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388959978VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388960448VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388961001VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
00199150001989MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2026-03-09
00763000521622MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-08-10
20763000722313ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-25
20763000722337ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-25
00763000722326ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-25
00763000722340ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-25
20763000722399MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-21
20763000722429MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-21
00763000722401MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-21
00763000722418MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-21
00763000988784Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-17
00763000988791Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-17
00763000651169Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-03-22
00763000521813MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-03-20
00763000714499MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-01-16
00763000714505MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-01-16
00763000714604MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-01-16
00763000930837MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-10-03
00763000714482MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-08-19
00763000714536MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-08-19
00763000714550MR8 ToolsMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-04-27
00763000732943MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-01-18