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Irrigation/Aspirating Handle

FDA UDI

Class I (US FDA UDI)

by Sontec Instruments, Inc.

Identity

Trade Name
IRRIGATION/ASPIRATING HANDLE FDA UDI
Generic Name
Ophthalmic irrigation/infusion/aspiration tubing, reusable FDA UDI
Device Name
IRRIGATION/ASPIRATING HANDLE FDA UDI
Model / Reference
16-7100 FDA UDI
Description
IRRIGATION/ASPIRATING HANDLE FDA UDI

Identifiers

Catalog Number
16-7100 FDA UDI
Primary DI / UDI-DI
00192896019287 FDA UDI
FDA Product Code
HMX FDA UDI
GMDN Term
Ophthalmic irrigation/infusion/aspiration tubing, 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

Dimensions & Sizes

Size
Length — 12.5 Centimeter FDA UDI

Category: Ophthalmic irrigation/infusion/aspiration tubing, reusable

Irrigation/Aspirating Handle by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic irrigation/infusion/aspiration tubing, 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 1ce55a46-588d-4d3d-9b9d-c3c277ee3edd 36 fields · synced May 30, 2026