AC DEVICE - Lockdown 5cm Acromiaclavicular (AC) Device - Lockdown Medical Ltd

Duns Number:211167885

Device Description: Lockdown 5cm Acromiaclavicular (AC) Device

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More Product Details

Catalog Number

LD050

Brand Name

AC DEVICE

Version/Model Number

LD050

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

K091207

Product Code Details

Product Code

HTN

Product Code Name

Washer, Bolt Nut

Device Record Status

Public Device Record Key

46fd19f8-17b6-4124-a6dd-c8b9757a1d2c

Public Version Date

November 23, 2021

Public Version Number

4

DI Record Publish Date

October 30, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LOCKDOWN MEDICAL LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 31