Fisherbrand - SPOONULA SS - FISHER SCIENTIFIC COMPANY L.L.C.

Duns Number:004321519

Device Description: SPOONULA SS

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More Product Details

Catalog Number

1437510EA

Brand Name

Fisherbrand

Version/Model Number

2857510EA

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

GAF

Product Code Name

SPATULA, SURGICAL, GENERAL & PLASTIC SURGERY

Device Record Status

Public Device Record Key

7a3f1049-e6a8-48d4-b1e1-f028e0451998

Public Version Date

September 27, 2022

Public Version Number

1

DI Record Publish Date

September 19, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FISHER SCIENTIFIC COMPANY L.L.C." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 129
2 A medical device with a moderate to high risk that requires special controls. 36