NAMIC - SYRINGE 10ML PP/FG RA OEM PG - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: SYRINGE 10ML PP/FG RA OEM PG

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More Product Details

Catalog Number

80095107

Brand Name

NAMIC

Version/Model Number

80095107

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

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

K873955,K873955

Product Code Details

Product Code

DXT

Product Code Name

Injector and syringe, angiographic

Device Record Status

Public Device Record Key

f467bfc2-19e0-4672-af36-f979eba083ef

Public Version Date

May 20, 2021

Public Version Number

1

DI Record Publish Date

May 12, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDLINE INDUSTRIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38540
2 A medical device with a moderate to high risk that requires special controls. 85094
3 A medical device with high risk that requires premarket approval 2
U Unclassified 7