LIF Access - BLUNT TIP, STAINLESS STEEL GUIDEWIRE, 320MM - ALPHATEC SPINE, INC.

Duns Number:602465783

Device Description: BLUNT TIP, STAINLESS STEEL GUIDEWIRE, 320MM

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More Product Details

Catalog Number

-

Brand Name

LIF Access

Version/Model Number

113-320-20

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

Yes

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

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Record Status

Public Device Record Key

f8d59354-75e8-4197-b358-8a55b532aa76

Public Version Date

November 23, 2021

Public Version Number

2

DI Record Publish Date

July 03, 2020

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