Needle - Needle - GALT MEDICAL CORP.

Duns Number:943156836

Device Description: Needle

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More Product Details

Catalog Number

NDL-112-00

Brand Name

Needle

Version/Model Number

NDL-112-00

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

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

DWS

Product Code Name

Instruments, Surgical, Cardiovascular

Device Record Status

Public Device Record Key

d966fd9f-91dc-463f-b26a-95ca2f19a49a

Public Version Date

May 31, 2019

Public Version Number

1

DI Record Publish Date

May 23, 2019

Additional Identifiers

Package DI Number

20841268108794

Quantity per Package

100

Contains DI Package

10841268108797

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box

"GALT MEDICAL CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 29
2 A medical device with a moderate to high risk that requires special controls. 696