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Bafna Phaco Free Tip with Silicone Sleeve

FDA UDI

Class I (US FDA UDI)

by Katalyst Surgical, Llc

Identity

Trade Name
Bafna Phaco Free Tip with Silicone Sleeve FDA UDI
Generic Name
Ophthalmic working-channel cannula, reusable FDA UDI
Device Name
Bafna Phaco Free Tip with Silicone Sleeve FDA UDI
Model / Reference
01619S-B FDA UDI
Description
Bafna Phaco Free Tip with Silicone Sleeve FDA UDI

Identifiers

Primary DI / UDI-DI
00840096205909 FDA UDI
FDA Product Code
HMX FDA UDI
GMDN Term
Ophthalmic working-channel cannula, 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Ophthalmic working-channel cannula, reusable

Bafna Phaco Free Tip with Silicone Sleeve by Katalyst Surgical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic working-channel cannula, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Katalyst Surgical, Llc

Sources (1)

  • FDA UDI 0eb68ddb-b5ea-44a2-adbf-b7e551ed47a8 33 fields · synced Jun 8, 2026