Wellstar Total Joint

GUDID 00817395023534

Wellstar Total Joint

PACKROOM LLC

Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use
Primary Device ID00817395023534
NIH Device Record Keyb2e700f9-fdfa-4ea7-85bc-d34a90ea142a
Commercial Distribution StatusIn Commercial Distribution
Brand NameWellstar Total Joint
Version Model NumberWS400.BO
Company DUNS015179820
Company NamePACKROOM LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817395023534 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-22
Device Publish Date2023-03-14

On-Brand Devices [Wellstar Total Joint ]

00817395021950Wellstar Total Joint
00817395023534Wellstar Total Joint

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