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 ID: 00817395022025
• NIH Device Record Key: 3c85ce91-b17f-4dab-8fda-34dced08b1c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wellstar C-Section
• Version Model Number: WS210
• Company DUNS: 015179820
• Company Name: PACKROOM LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817395022025 [Primary]
GS1	00817395022025 [Primary]
GS1	00817395022025 [Primary]
GS1	00817395022025 [Primary]
GS1	00817395022025 [Primary]
GS1	00817395022025 [Primary]
GS1	00817395022025 [Primary]
GS1	00817395022025 [Primary]
GS1	00817395022025 [Primary]
GS1	00817395022025 [Primary]
GS1	00817395022025 [Primary]
GS1	00817395022025 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-23
• Device Publish Date: 2021-02-15

Devices Manufactured by PACKROOM LLC

• 00817395022025 - Wellstar C-Section: 2021-02-23Wellstar C-Section
• 00817395022025 - Wellstar C-Section: 2021-02-23 Wellstar C-Section
• 00817395022018 - Wellstar Gen Maj Abdominal: 2021-02-11 Wellstar Gen Maj Abdominal
• 00817395021783 - Wellstar Cath Lab: 2020-11-06 Wellstar Cath Lab
• 00817395021981 - Kennestone T & A: 2020-10-29 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