Wellstar Total Joint (157008)

GUDID 00817395023060

Wellstar Total Joint (157008)

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
Primary Device ID00817395023060
NIH Device Record Keyb03a9892-7166-42da-afd3-25c44dea8034
Commercial Distribution StatusIn Commercial Distribution
Brand NameWellstar Total Joint (157008)
Version Model NumberWS400A
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
GS100817395023060 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-28
Device Publish Date2022-04-20

Devices Manufactured by PACKROOM LLC

00817395023848 - NGHS Tubal RFID 2024-04-01 NGHS Tubal RFID
00817395023824 - NEGA Open Heart *RFID PB2024-03-27 NEGA Open Heart *RFID PB
00817395023831 - Lithotomy Pack *RFID PB2024-03-27 Lithotomy Pack *RFID PB
00817395023596 - Barrow Podiatry *RFID PB2024-03-26 Barrow Podiatry *RFID PB
00817395023602 - NEGA Arthroscopy *RFID PB2024-03-26 NEGA Arthroscopy *RFID PB
00817395023619 - NEGA Thoracic CVOR *RFID PB2024-03-26 NEGA Thoracic CVOR *RFID PB
00817395023626 - NEGA C-Section *RFID PB2024-03-26 NEGA C-Section *RFID PB Huntsville Vag Perineal
00817395023633 - NEGA Cysto *RFID PB2024-03-26 NEGA Cysto *RFID PB

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