Globus Medical, Inc. 6203.2011S

GUDID 26975424192564

Drape, ExcelsiusHub™ Skirt, GNS

EXACT MEDICAL MANUFACTURING, INC.

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Primary Device ID26975424192564
NIH Device Record Keyd3f79887-3466-4f98-aa7c-ec0dc4550b2e
Commercial Distribution StatusIn Commercial Distribution
Brand NameGlobus Medical, Inc.
Version Model Number6203.2011S
Catalog Number6203.2011S
Company DUNS014464314
Company NameEXACT MEDICAL MANUFACTURING, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106975424192553 [Primary]
GS126975424192564 [Package]
Contains: 06975424192553
Package: Case [10 Units]
In Commercial Distribution

FDA Product Code

KKXDrape, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-17
Device Publish Date2023-08-09

On-Brand Devices [Globus Medical, Inc.]

16975424192833ExcelsiusFLEX™-TKA Drape
26975424192564Drape, ExcelsiusHub™ Skirt, GNS
26975424192540Drape, ExcelsiusHub™ Monitor, GNS

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