Catalog Number

705-10

Brand Name

SPIRO

Version/Model Number

705

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GEN

Product Code Name

Forceps, General & Plastic Surgery

Public Device Record Key

0567393e-e531-4355-989b-97444febd7c9

Public Version Date

July 23, 2020

Public Version Number

4

DI Record Publish Date

March 31, 2018

Package DI Number

07350061231077

Quantity per Package

5

Contains DI Package

07350061231060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Zip-Lock Bag