Aptus

FDA UDI

Class II (US FDA UDI)

by Medartis Inc.

Identity

Trade Name: APTUS FDA UDI
Generic Name: Surgical implant template, reusable FDA UDI
Device Name: Template for plate A-4851.01 FDA UDI
Model / Reference: A-4851.01TP FDA UDI
Description: Template for plate A-4851.01 FDA UDI

Identifiers

Catalog Number: A-4851.01TP FDA UDI
Primary DI / UDI-DI: 07630037829201 FDA UDI
510(k) Number: K192984 FDA UDI
FDA Product Code: HRS FDA UDI
GMDN Term: Surgical implant template, reusable 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

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical implant template, reusable

Aptus by Medartis Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K192984 also covers:

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: Medartis Inc.

Sources (1)

FDA UDI cecc0355-5a0f-40fe-8314-8e50875b8c65 35 fields · synced May 30, 2026