SafePath - One pouched device, 1F001 - Safepath Medical, Inc.

Duns Number:877189584

Device Description: One pouched device, 1F001

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More Product Details

Catalog Number

1F001

Brand Name

SafePath

Version/Model Number

1F001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 2023

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

GAP

Product Code Name

Suture, Nonabsorbable, Silk

Device Record Status

Public Device Record Key

319c3fc3-0074-45a2-aee4-0749ad833ed9

Public Version Date

February 07, 2022

Public Version Number

1

DI Record Publish Date

January 28, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SAFEPATH MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2