Disposable Loop-X Source Drape (1 Pc)

GUDID 04056481145941

The source drape is intended to sterile cover the source (cone beam) of the Loop-X.

Brainlab AG

Medical equipment/instrument drape, single-use
Primary Device ID04056481145941
NIH Device Record Key7a5ef19e-ea20-4a6c-a213-032b855c8660
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Loop-X Source Drape (1 Pc)
Version Model Number22183-12
Company DUNS314482980
Company NameBrainlab AG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481145941 [Package]
Contains: 04056481146009
Package: [5 Units]
In Commercial Distribution
GS104056481146009 [Primary]

FDA Product Code

PUIDrape, Surgical, Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-04
Device Publish Date2025-07-25

Devices Manufactured by Brainlab AG

04056481145941 - Disposable Loop-X Source Drape (1 Pc)2025-08-04The source drape is intended to sterile cover the source (cone beam) of the Loop-X.
04056481145941 - Disposable Loop-X Source Drape (1 Pc)2025-08-04 The source drape is intended to sterile cover the source (cone beam) of the Loop-X.
04056481145330 - CRANIAL 4PI HEADREST PLATFORM2025-07-04
04056481145347 - CRANIAL 4PI HEAD SUPPORT STANDARD2025-07-04
04056481145354 - CRANIAL 4PI STEREOTACTIC MASK 3.2MM (5 PCS.)2025-07-04
04056481145361 - CRANIAL 4PI WEDGE 10 DEG.2025-07-04
04056481145378 - CRANIAL 4PI SPACER 20MM2025-07-04
04056481145453 - CRANIAL 4PI INDEXING PLATE2025-07-04
04056481145460 - CRANIAL 4PI HEAD SUPPORT WIDE2025-07-04

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