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Bausch + Lomb

FDA UDI

Class II (US FDA UDI)

by Bausch & Lomb Incorporated

Identity

Trade Name
Bausch + Lomb FDA UDI
Generic Name
Vitrectomy system FDA UDI
Device Name
23 Ga. Vitesse handpiece 175+ESA FDA UDI
Model / Reference
BL5631 FDA UDI
Description
23 Ga. Vitesse handpiece 175+ESA FDA UDI

Identifiers

Catalog Number
BL5631 FDA UDI
Primary DI / UDI-DI
20757770059144 FDA UDI
FDA Product Code
HQE FDA UDI
HQC FDA UDI
GMDN Term
Vitrectomy system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.4150 FDA UDI
886.4670 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Vitrectomy system

Bausch + Lomb by Bausch & Lomb Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vitrectomy system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bausch & Lomb Incorporated

Sources (1)

  • FDA UDI 8163bd53-a557-4bb3-b907-f00dc33ac58d 34 fields · synced Jun 6, 2026