Loop-X Disposable Sterile Drape Set - The Loop-X Disposable Sterile Drape Set is an - Brainlab AG

Duns Number:314482980

Device Description: The Loop-X Disposable Sterile Drape Set is an accessory for the Loop-X imaging device. The The Loop-X Disposable Sterile Drape Set is an accessory for the Loop-X imaging device. The drape set creates a sterile barrier between the OR field and the imaging device, allowing intraoperative 2D imaging of patients in a sterile environment.

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More Product Details

Catalog Number

-

Brand Name

Loop-X Disposable Sterile Drape Set

Version/Model Number

22183-01

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

PUI

Product Code Name

Drape, Surgical, Exempt

Device Record Status

Public Device Record Key

1a298037-c977-4981-9026-43a3f342a893

Public Version Date

October 20, 2021

Public Version Number

1

DI Record Publish Date

October 12, 2021

Additional Identifiers

Package DI Number

04056481142827

Quantity per Package

5

Contains DI Package

04056481143299

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"BRAINLAB AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 48
2 A medical device with a moderate to high risk that requires special controls. 685