HER-SPEC - VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE - OBP CORPORATION

Duns Number:011560431

Device Description: VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE SMALL - STERILE

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More Product Details

Catalog Number

-

Brand Name

HER-SPEC

Version/Model Number

C020600

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code Details

Product Code

HIB

Product Code Name

Speculum, Vaginal, Nonmetal

Device Record Status

Public Device Record Key

3a0c5e38-b627-4c4d-80a1-df7c5c2ec19e

Public Version Date

October 31, 2019

Public Version Number

1

DI Record Publish Date

October 23, 2019

Additional Identifiers

Package DI Number

M648C0206002

Quantity per Package

64

Contains DI Package

M648C0206001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"OBP CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 23
2 A medical device with a moderate to high risk that requires special controls. 22