Intrector®

FDA UDI

Class II (US FDA UDI)

by Insight Instruments, Inc.

Identity

Trade Name: INTRECTOR® FDA UDI
Generic Name: Vitrectomy system handpiece FDA UDI
Device Name: INTRECTOR® Handpiece for use with the INTRECTOR® Portable Vitrectomy System REF: 71200 FDA UDI
Model / Reference: 71101 FDA UDI
Description: INTRECTOR® Handpiece for use with the INTRECTOR® Portable Vitrectomy System REF: 71200 FDA UDI

Identifiers

Catalog Number: 71101 FDA UDI
Primary DI / UDI-DI: 00856222004193 FDA UDI
FDA Product Code: HKP FDA UDI
GMDN Term: Vitrectomy system handpiece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.4150 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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Vitrectomy system handpiece

Intrector® by Insight Instruments, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Insight Instruments, Inc.

Sources (1)

FDA UDI b24895c9-129a-4255-b6a3-e8c48726bca8 35 fields · synced May 30, 2026