Intrector®

FDA UDI

Class II (US FDA UDI)

by Insight Instruments, Inc.

Identity

Trade Name: INTRECTOR® FDA UDI
Generic Name: Vitrectomy system handpiece tip FDA UDI
Device Name: 1 Disposable 23 Ga Vitrectomy Probe for use with the INTRECTOR® KIT FDA UDI
Model / Reference: 71004.100 FDA UDI
Description: 1 Disposable 23 Ga Vitrectomy Probe for use with the INTRECTOR® KIT FDA UDI

Identifiers

Primary DI / UDI-DI: 00856222004643 FDA UDI
FDA Product Code: HKP FDA UDI
GMDN Term: Vitrectomy system handpiece tip 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 23 Gauge FDA UDI

Category: Vitrectomy system handpiece tip

Intrector® by Insight Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vitrectomy system handpiece tip.

Synergetics — SYNERGETICS USA, INC. · Class II
Synergetics — SYNERGETICS USA, INC. · Class II
Synergetics — SYNERGETICS USA, INC. · Class II
LAUREATE Alcon Grieshaber — Alcon Laboratories, Inc. · Class II
INTRECTOR® — INSIGHT INSTRUMENTS, INC.
RETRECTOR® — INSIGHT INSTRUMENTS, INC.
RETRECTOR® — INSIGHT INSTRUMENTS, INC. · Class II
Insight Instruments, Inc. Vitreous Biopsy Probe 27 Ga — INSIGHT INSTRUMENTS, INC. · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Insight Instruments, Inc.

Sources (1)

FDA UDI 09621cee-e689-4953-ba16-9a8a8ee976d3 35 fields · synced May 30, 2026