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Journey Uni

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
Journey Uni FDA UDI
Generic Name
Bone punch, reusable FDA UDI
Device Name
MODULAR IMPACTOR HEAD FDA UDI
Model / Reference
E0014599-13 FDA UDI
Description
MODULAR IMPACTOR HEAD FDA UDI

Identifiers

Catalog Number
E0014599-13 FDA UDI
Primary DI / UDI-DI
00885556623510 FDA UDI
510(k) Number
K113038 FDA UDI
FDA Product Code
HSX FDA UDI
GMDN Term
Bone punch, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3520 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Bone punch, reusable

Journey Uni by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone punch, reusable.

Cleared under the same submission

K113038 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI 219bb0b7-dd8f-4489-93bb-b7f11b4a49f3 36 fields · synced Jun 8, 2026