Ryder Needle Holder - Ryder Needle Holder Tungsten Carbide Serrated Jaw - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: Ryder Needle Holder Tungsten Carbide Serrated Jaw Streamline Quantum

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More Product Details

Catalog Number

-

Brand Name

Ryder Needle Holder

Version/Model Number

2300-313Q

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

FHQ

Product Code Name

HOLDER, NEEDLE, GASTROENTEROLOGIC

Device Record Status

Public Device Record Key

1cfd5c37-044f-498f-8509-23a9d8b7f335

Public Version Date

October 04, 2021

Public Version Number

1

DI Record Publish Date

September 24, 2021

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