LUMEX - CANVAS 1-PIECE SLING - GF HEALTH PRODUCTS, INC.

Duns Number:132016168

Device Description: CANVAS 1-PIECE SLING

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More Product Details

Catalog Number

GF112-C-LC

Brand Name

LUMEX

Version/Model Number

GF112-C-LC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

FSA

Product Code Name

Lift, Patient, Non-Ac-Powered

Device Record Status

Public Device Record Key

c7e7e432-805c-4a95-ae35-6cb3a07c84d9

Public Version Date

June 16, 2021

Public Version Number

1

DI Record Publish Date

June 08, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GF HEALTH PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1068
2 A medical device with a moderate to high risk that requires special controls. 202