Oral Tamper Evident Cap - Oral Tamper Evident Cap for Comar Oral Dispenser. - INTERNATIONAL MEDICAL INDUSTRIES INC.

Duns Number:053469565

Device Description: Oral Tamper Evident Cap for Comar Oral Dispenser. Non-Sterile, Bag of 100, Box of 1000. Pr Oral Tamper Evident Cap for Comar Oral Dispenser. Non-Sterile, Bag of 100, Box of 1000. Provides Evidence of Access and Positive Closure

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More Product Details

Catalog Number

57-74

Brand Name

Oral Tamper Evident Cap

Version/Model Number

57-74

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"

-

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

KYX

Product Code Name

Dispenser, Liquid Medication

Device Record Status

Public Device Record Key

785818b5-b527-47a1-a807-62654ec0b1f6

Public Version Date

October 29, 2021

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

B21257742

Quantity per Package

10

Contains DI Package

B21257741

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"INTERNATIONAL MEDICAL INDUSTRIES INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 15