Intra-Lock - INTERNAL HEX CLOSED TRAY TRANSFER - INTRA-LOCK INTERNATIONAL, INC.

Duns Number:131500998

Device Description: INTERNAL HEX CLOSED TRAY TRANSFER

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More Product Details

Catalog Number

IHT

Brand Name

Intra-Lock

Version/Model Number

IHT

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)

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

OFY

Product Code Name

Dental Implant Surgical Tray

Device Record Status

Public Device Record Key

f4902cf8-6a5e-4043-9816-c19c805a535e

Public Version Date

July 18, 2019

Public Version Number

1

DI Record Publish Date

July 10, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTRA-LOCK INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 329
2 A medical device with a moderate to high risk that requires special controls. 918