Globus Medical, Inc. 6203.2010S

GUDID 26975424192540

Drape, ExcelsiusHub™ Monitor, GNS

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use
Primary Device ID26975424192540
NIH Device Record Key7da900c4-a565-4e3c-a87f-2442c772f0dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameGlobus Medical, Inc.
Version Model Number6203.2010S
Catalog Number6203.2010S
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
GS106975424192539 [Primary]
GS126975424192540 [Package]
Contains: 06975424192539
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.