EOS - EosSpec I-EOS DISPOSABLE VAGINAL SPECULUM, SMALL - NORTH EOS INDUSTRIES INC.

Duns Number:656812989

Device Description: EosSpec I-EOS DISPOSABLE VAGINAL SPECULUM, SMALL SIZE(CUSCO)

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More Product Details

Catalog Number

-

Brand Name

EOS

Version/Model Number

EosSpec I -SMALL

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"

Yes

For Single-Use

Yes

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

K963377

Product Code Details

Product Code

HIB

Product Code Name

Speculum, Vaginal, Nonmetal

Device Record Status

Public Device Record Key

dd914ad4-bb2a-4e20-aae5-77bfdb535aea

Public Version Date

September 10, 2018

Public Version Number

1

DI Record Publish Date

August 10, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NORTH EOS INDUSTRIES INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 48
2 A medical device with a moderate to high risk that requires special controls. 23