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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
27 ga. Bi-Blade Vitrectomy Cutter, 7500 cpm FDA UDI
Model / Reference
SE5627B FDA UDI
Description
27 ga. Bi-Blade Vitrectomy Cutter, 7500 cpm FDA UDI

Identifiers

Catalog Number
SE5627B FDA UDI
Primary DI / UDI-DI
10757770059727 FDA UDI
FDA Product Code
HQC FDA UDI
HQE FDA UDI
GMDN Term
Vitrectomy system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.4670 FDA UDI
886.4150 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 4956e19e-854c-4b27-93ea-9b6e2265d8ed 34 fields · synced Jun 8, 2026