Intacs Procedure Marker

FDA UDI

Class I (US FDA UDI)

by Addition Technology

Identity

Trade Name: Intacs Procedure Marker FDA UDI
Generic Name: Corneal marker, reusable FDA UDI
Device Name: The Procedure Marker, 0.9 mm is used for marking the 1.2 mm incision and the placement marks for the 150 degree Intacs® Corneal Implants by aligning the reticle with the center mark that has been created on the cornea. This multi-functional device is also used later in the surgical procedure to align the Vacuum Centering Guide on the cornea. FDA UDI
Model / Reference: KV10733 FDA UDI
Description: The Procedure Marker, 0.9 mm is used for marking the 1.2 mm incision and the placement marks for the 150 degree Intacs® Corneal Implants by aligning the reticle with the center mark that has been created on the cornea. This multi-functional device is also used later in the surgical procedure to align the Vacuum Centering Guide on the cornea. FDA UDI

Identifiers

Primary DI / UDI-DI: 00850048576032 FDA UDI
FDA Product Code: HMR FDA UDI
GMDN Term: Corneal marker, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4570 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

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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Corneal marker, reusable

Intacs Procedure Marker by Addition Technology — 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: Addition Technology

Sources (1)

FDA UDI 63f63547-6516-482e-97e8-901eed552594 33 fields · synced May 30, 2026