General Instrument - Custom 5.5 Rod Holder - ALPHATEC SPINE, INC.

Duns Number:602465783

Device Description: Custom 5.5 Rod Holder

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More Product Details

Catalog Number

-

Brand Name

General Instrument

Version/Model Number

CI-10796

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)

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

HTD

Product Code Name

FORCEPS

Device Record Status

Public Device Record Key

89bb217d-cd0d-4da3-b772-81124bc0b3ce

Public Version Date

October 21, 2022

Public Version Number

1

DI Record Publish Date

October 13, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALPHATEC SPINE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5644
2 A medical device with a moderate to high risk that requires special controls. 26570
U Unclassified 15