Profyle

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name: PROFYLE FDA UDI
Generic Name: Implantable bone washer FDA UDI
Device Name: WASHER FOR 1.7MM BONE SCREWS FDA UDI
Model / Reference: 59-17049S FDA UDI
Description: WASHER FOR 1.7MM BONE SCREWS FDA UDI

Identifiers

Catalog Number: 59-17049S FDA UDI
Primary DI / UDI-DI: 04546540542946 FDA UDI
FDA Product Code: HRS FDA UDI
GMDN Term: Implantable bone washer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Category: Implantable bone washer

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

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Monster Screw System — Paragon 28 · Class II
FLAT WASHER — Biomet Orthopedics, Inc. · Class II
Fixcet Spinal Facet Screw System — Xtant Medical Holdings, Inc. · U
LEOS Cannulated Screw System — Tyber Medical · 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 5250105e-df52-4a69-ac82-1b6cd5be9b7b 35 fields · synced May 31, 2026