DEVICE: Zyphr (04546540716224)

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Device Identifier (DI) Information

Zyphr
5100060001
5100060001
STRYKER CORPORATION
04546540716224
GS1
1
Zyphr Disposable Cranial Perforator, Large 14/11mm
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Automatic cranial perforator, single-use A sterile, drill-like, device 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 drills (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 extends slightly beyond the outer cutter in such a way that when the inner drill penetrates the inner table of the skull the clutch mechanism disengages. It is typically made of high-grade stainless steel. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
HBF DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Lumen/Inner Diameter: 11.0 Millimeter
Outer Diameter: 14.0 Millimeter
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Device Status

In Commercial Distribution
September 23, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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+1(800)253-3210
Inst.Stryker.cs@Stryker.com
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