Level 1 - SMITHS MEDICAL MD, INC.

Duns Number:106712748

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More Product Details

Catalog Number

-

Brand Name

Level 1

Version/Model Number

FC400-10

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

K873448,K873448

Product Code Details

Product Code

KOD

Product Code Name

CATHETER, UROLOGICAL

Device Record Status

Public Device Record Key

8e2c7dcf-556a-4039-9a28-993b7f1e9b95

Public Version Date

December 04, 2020

Public Version Number

10

DI Record Publish Date

October 14, 2016

Additional Identifiers

Package DI Number

30695085000475

Quantity per Package

20

Contains DI Package

10695085000471

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"SMITHS MEDICAL MD, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 686
3 A medical device with high risk that requires premarket approval 2
U Unclassified 1