FDA.reportPublic FDA data

NA

Primary DI
04546540078209
Brand
NA
Company
STRYKER CORPORATION
Model
5120012065
Catalog number
5120-012-065
Device description
6.5mm Diamond Round
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
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540078209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540078209045465400782094546540078209

GMDN Terms#

Term, Definition table
TermDefinition
Cranial bur, single-useA rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal and/or diamond material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate soft or hard skull tissue. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
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
Lot or batch
true
Expiration date on label
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04589551366590Sterile Cutting ToolNAKANISHI INC.HBE2026-05-22
04589551366606Sterile Cutting ToolNAKANISHI INC.HBE2026-05-22
04589551366613Sterile Cutting ToolNAKANISHI INC.HBE2026-05-22
B775635CK0PHASORPHASOR HEALTH LLCHBE2026-01-19
B7752IN125LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7752IN126K0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7752IN126LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7752IN145LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7753IN1246K0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7753IN1246LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7753IN1256LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7754IN1K0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7754IN1LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7755IN1LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B775GREDBA0PHASORPHASOR HEALTH LLCHBE2025-11-24
B775GREDRI0PHASORPHASOR HEALTH LLCHBE2025-11-24
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00763000722319ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBE2025-07-25
00763000722418MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBE2025-07-21
00763000988784Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBE2025-07-17
00763000892722Midas Rex ClearviewMEDTRONIC XOMED, INC.HBE2025-06-23
06429811532069Surgify Halo 4.0 mm ShortSurgify Medical OyHBE2025-06-18
06429811532076Surgify Halo 4.0 mm ExtendableSurgify Medical OyHBE2025-06-18
06429811532083Surgify Halo 4.0 mm LongSurgify Medical OyHBE2025-06-18
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