UNIVERSAL SUCTION TUBE CLIP ON - UNIVERSAL SUCTION TUBE CLIP ON ATTACHMENT - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: UNIVERSAL SUCTION TUBE CLIP ON ATTACHMENT

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More Product Details

Catalog Number

1301-099

Brand Name

UNIVERSAL SUCTION TUBE CLIP ON

Version/Model Number

1301-099

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

-

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

JOL

Product Code Name

CATHETER AND TIP, SUCTION

Device Record Status

Public Device Record Key

92c80add-db9c-4b6a-a921-bcf764a55f50

Public Version Date

July 29, 2020

Public Version Number

4

DI Record Publish Date

March 07, 2019

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