PIGTAIL LACRIMAL PROBE - PIGTAIL LACRIMAL PROBE WITH HOLES - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: PIGTAIL LACRIMAL PROBE WITH HOLES

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More Product Details

Catalog Number

16-2600

Brand Name

PIGTAIL LACRIMAL PROBE

Version/Model Number

16-2600

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

HNL

Product Code Name

Probe, lachrymal

Device Record Status

Public Device Record Key

d8abbb45-e6da-485b-b0f9-52f2c7d23588

Public Version Date

October 19, 2018

Public Version Number

1

DI Record Publish Date

September 18, 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