Integra® Jarit® - Sauer Eye Speculum, 1-1/4", Infant, 11.5mm - INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Duns Number:081277700

Device Description: Sauer Eye Speculum, 1-1/4", Infant, 11.5mm Blades, 20mm Spread

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More Product Details

Catalog Number

350-097

Brand Name

Integra® Jarit®

Version/Model Number

350097

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

HNC

Product Code Name

Specula, ophthalmic

Device Record Status

Public Device Record Key

f0a28cd1-2e61-4a80-a89e-94925c7fa8f6

Public Version Date

November 03, 2021

Public Version Number

4

DI Record Publish Date

October 31, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTEGRA LIFESCIENCES PRODUCTION CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15051
2 A medical device with a moderate to high risk that requires special controls. 4286
3 A medical device with high risk that requires premarket approval 2
U Unclassified 3