Bausch + Lomb - LASER INDIRECT OPHTHALMOSCOPE - Bausch & Lomb Incorporated

Duns Number:196603781

Device Description: LASER INDIRECT OPHTHALMOSCOPE

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More Product Details

Catalog Number

BL2298

Brand Name

Bausch + Lomb

Version/Model Number

BL2298

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

HQF

Product Code Name

Laser, Ophthalmic

Device Record Status

Public Device Record Key

3f2ca547-f807-489d-9413-d83a02dc1145

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BAUSCH & LOMB INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 77
2 A medical device with a moderate to high risk that requires special controls. 134
3 A medical device with high risk that requires premarket approval 3348
U Unclassified 1