Zyphr

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name: Zyphr FDA UDI
Generic Name: Automatic cranial perforator, single-use FDA UDI
Device Name: Zyphr Disposable Cranial Perforator, Large 14/11mm FDA UDI
Model / Reference: 5100060001 FDA UDI
Description: Zyphr Disposable Cranial Perforator, Large 14/11mm FDA UDI

Identifiers

Catalog Number: 5100-060-001 FDA UDI
Primary DI / UDI-DI: 04546540716224 FDA UDI
FDA Product Code: HBF FDA UDI
GMDN Term: Automatic cranial perforator, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4305 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Lumen/Inner Diameter — 11.0 Millimeter FDA UDI
Outer Diameter — 14.0 Millimeter FDA UDI

Category: Automatic cranial perforator, single-use

Zyphr by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Automatic cranial perforator, single-use.

PHASOR — Phasor Health, LLC · Class II
EasyDrill Cranial Perforator Ø9 x Ø6 x 3mm — Micromar Indústria e Comércio Ltda · Class II
EasyDrill Cranial Perforator Ø9 x Ø6 x 3mm — Micromar Indústria e Comércio Ltda · Class II
Evonos — Evonos GmbH & Co. KG · Class II
Evonos — Evonos GmbH & Co. KG · Class II
EasyDrill Cranial Perforator Ø14 x Ø11 x 1, 5mm — Micromar Indústria e Comércio Ltda · Class II
ACRA-CUT — ACRA-CUT INC · Class II
PHASOR — Phasor Health, LLC · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Stryker Corp.

Sources (1)

FDA UDI ae276aa8-536e-4275-a7d2-f1c53ce0c6f2 36 fields · synced Jun 6, 2026