Wellstar C-Section

GUDID 00817395022025

Wellstar C-Section

PACKROOM LLC

Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
Primary Device ID00817395022025
NIH Device Record Key3c85ce91-b17f-4dab-8fda-34dced08b1c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameWellstar C-Section
Version Model NumberWS210
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
GS100817395022025 [Primary]
GS100817395022025 [Primary]
GS100817395022025 [Primary]
GS100817395022025 [Primary]
GS100817395022025 [Primary]
GS100817395022025 [Primary]
GS100817395022025 [Primary]
GS100817395022025 [Primary]
GS100817395022025 [Primary]
GS100817395022025 [Primary]
GS100817395022025 [Primary]
GS100817395022025 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-23
Device Publish Date2021-02-15

Devices Manufactured by PACKROOM LLC

00817395022025 - Wellstar C-Section2021-02-23Wellstar C-Section
00817395022025 - Wellstar C-Section2021-02-23 Wellstar C-Section
00817395022018 - Wellstar Gen Maj Abdominal2021-02-11 Wellstar Gen Maj Abdominal
00817395021783 - Wellstar Cath Lab2020-11-06 Wellstar Cath Lab
00817395021981 - Kennestone T & A2020-10-29 Kennestone T & A
00817395021875 - Wellstar Laparoscopy 2020-10-21 Wellstar Laparoscopy
00817395021882 - Wellstar Spine 2020-10-21 Wellstar Spine
00817395021899 - Phoebe Main Head & Neck 2020-10-21 Phoebe Main Head & Neck
00817395021905 - Phoebe Main Heart Valve 2020-10-21 Phoebe Main Heart Valve

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