Safer Lock - Safer Lock - Rx Locking Cap OTC - Gatekeeper Innovation, Inc.

Duns Number:028113963

Device Description: Safer Lock - Rx Locking Cap OTC

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More Product Details

Catalog Number

-

Brand Name

Safer Lock

Version/Model Number

1000092

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NXB

Product Code Name

Dispenser, solid medication

Device Record Status

Public Device Record Key

2cff6b97-053f-4f80-8d49-85e48056fb6b

Public Version Date

October 23, 2019

Public Version Number

2

DI Record Publish Date

September 27, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GATEKEEPER INNOVATION, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6