FDA.reportPublic FDA data

Zyphr

Primary DI
04546540716224
Brand
Zyphr
Company
STRYKER CORPORATION
Model
5100060001
Catalog number
5100-060-001
Device description
Zyphr Disposable Cranial Perforator, Large 14/11mm
Published
2016-09-23
Public version status
Update
Distribution status
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
HBFDRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)Neurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540716224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540716224045465407162244546540716224

GMDN Terms#

Term, Definition table
TermDefinition
Automatic cranial perforator, single-useA sterile, metallic rotary endpiece designed to cut a circular section, or sections, of the skull vault (calvarium) to provide access to the interior for diagnostic/therapeutic purposes or for the removal of a bone flap for brain surgery. It typically consists of two coaxial drill shafts (one rotating inside the other), a drive shank that enables connection to a powered (either electrical or pneumatic) handpiece, and a built-in clutch mechanism. The inner drill shaft extends slightly beyond the outer cutter in such a way that when the inner drill shafts penetrates the inner table of the skull the clutch mechanism disengages. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter11Millimeter
Outer Diameter14Millimeter

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
07613327651119VersiQuad0234112012234-112-0122026-07-16
07613327651126VersiQuad0234112611234-112-6112026-07-16
07613327651133VersiQuad0234112100234-112-1002026-07-16
07613327651140VersiQuad0234112608234-112-6082026-07-16
07613327651157VersiQuad0234112109234-112-1092026-07-16
07613327651164VersiQuad0234112500234-112-5002026-07-16
07613327651171VersiQuad0234112108234-112-1082026-07-16
07613327651195VersiQuad0234112607234-112-6072026-07-16
07613327651201VersiQuad0234112110234-112-1102026-07-16
07613327651218VersiQuad0234112609234-112-6092026-07-16
07613327651225VersiQuad0234112610234-112-6102026-07-16
07613327507935Stroke Fast PackSFP913140SFP9131402020-06-30
07613327507942Stroke Fast PackSFP913150SFP9131502020-06-30
07613327507959Stroke Fast PackSFP913160SFP9131602020-06-30
07613327507966Stroke Fast PackSFP913170SFP9131702020-06-30
07613327507973Stroke Fast PackSFP913180SFP9131802020-06-30
07613327507980Stroke Fast PackSFP913190SFP9131902020-06-30
07613327507997Stroke Fast PackSFP913100SFP9131002020-06-30
07613327635096InZone ISTIST345100960IST3451009602026-07-08
07613327638233Omnicurve10320150001032-015-0002024-09-03

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