Symmetry Karlin™

FDA UDI

Class I (US FDA UDI)

by Symmetry Surgical Inc.

Identity

Trade Name: Symmetry Karlin™ FDA UDI
Generic Name: Orthopaedic implant impactor, reusable FDA UDI
Device Name: Symmetry® Impactor, Central Canal, Tip Oriented 30° From Vertical, 1/2 in Tip Length, 7/32 in Wide Tip, 8 3/4 in FDA UDI
Model / Reference: 46-3008 FDA UDI
Description: Symmetry® Impactor, Central Canal, Tip Oriented 30° From Vertical, 1/2 in Tip Length, 7/32 in Wide Tip, 8 3/4 in FDA UDI

Identifiers

Catalog Number: 46-3008 FDA UDI
Primary DI / UDI-DI: 00887482013694 FDA UDI
FDA Product Code: HWA FDA UDI
GMDN Term: Orthopaedic implant impactor, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Width — 0.21875 Inch FDA UDI
Depth — 0.5 Inch FDA UDI
Angle — 30 degree FDA UDI
Length — 8.75 Inch FDA UDI

Category: Orthopaedic implant impactor, reusable

Symmetry Karlin™ by Symmetry Surgical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Symmetry Surgical Inc.

Sources (1)

FDA UDI 4b0662af-91e6-46c0-b04a-1b6a05ce03e1 36 fields · synced May 31, 2026