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Jaffe Iris Hook

FDA UDI

Class I (US FDA UDI)

by Sontec Instruments, Inc.

Identity

Trade Name
JAFFE IRIS HOOK FDA UDI
Generic Name
Eye muscle hook, reusable FDA UDI
Device Name
JAFFE IRIS HOOK BLUNT TIP FDA UDI
Model / Reference
12-5440 FDA UDI
Description
JAFFE IRIS HOOK BLUNT TIP FDA UDI

Identifiers

Catalog Number
12-5440 FDA UDI
Primary DI / UDI-DI
00192896013674 FDA UDI
FDA Product Code
HNQ FDA UDI
GMDN Term
Eye muscle hook, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.4350 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Eye muscle hook, reusable

Jaffe Iris Hook by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Eye muscle hook, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sontec Instruments, Inc.

Sources (1)

  • FDA UDI 79a7009c-6aa1-4f4e-b136-29fbc19f1175 35 fields · synced May 31, 2026