BISHOP-HARMON PLASTIC ADAPTOR - BISHOP-HARMON PLASTIC ADAPTOR - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: BISHOP-HARMON PLASTIC ADAPTOR

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More Product Details

Catalog Number

16-5321

Brand Name

BISHOP-HARMON PLASTIC ADAPTOR

Version/Model Number

16-5321

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

HMX

Product Code Name

Cannula, ophthalmic

Device Record Status

Public Device Record Key

9919f691-cd18-4f9f-a632-8e2bc977b73f

Public Version Date

November 26, 2018

Public Version Number

1

DI Record Publish Date

October 24, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONTEC INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10108
2 A medical device with a moderate to high risk that requires special controls. 3414