Bausch + Lomb - TRAY STERILIZATION HOLDS 15 - Bausch & Lomb Incorporated

Duns Number:196603781

Device Description: TRAY STERILIZATION HOLDS 15

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More Product Details

Catalog Number

E7416 1

Brand Name

Bausch + Lomb

Version/Model Number

E7416 1

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

FSM

Product Code Name

Tray, Surgical, Instrument

Device Record Status

Public Device Record Key

f5b20e49-4a59-40ac-95fe-7c4aa87d25a4

Public Version Date

September 16, 2022

Public Version Number

8

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