SURGICEL 3123SPEA

GUDID 20705031237510

Endoscopic Applicator

ETHICON, LLC

Haematological concentrate/haemostatic agent cannula, endoscopic, single-use Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use

• Primary Device ID: 20705031237510
• NIH Device Record Key: 34030087-c4ed-4fd9-814e-2efa4ff785d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURGICEL
• Version Model Number: 3123SPEA
• Catalog Number: 3123SPEA
• Company DUNS: 829465157
• Company Name: ETHICON, 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031237513 [Primary]
GS1	20705031237510 [Package]; Contains: 10705031237513; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: N12159

FDA Product Code

• LMG: Agent, absorbable hemostatic, non-collagen based

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-22
• Device Publish Date: 2019-05-13

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• 10705031470552 - ETHICON SECURESTRAP: 2024-02-01 ETHICON SECURESTRAP ABSORBABLE FIXATION DEVICE
• 30705031204113 - PDS: 2023-11-08 Antibacterial Violet Monofilament (Polydioxanone), Absorbable Surgical Suture
• 30705031204175 - PDS: 2023-11-08 Antibacterial Violet Monofilament (Polydioxanone), Absorbable Surgical Suture
• 30705031204236 - PDS: 2023-11-08 Antibacterial Violet Monofilament (Polydioxanone), Absorbable Surgical Suture
• 30705031204250 - PDS: 2023-11-08 Antibacterial Violet Monofilament (Polydioxanone), Absorbable Surgical Suture
• 30705031204274 - PDS: 2023-11-08 Antibacterial Violet Monofilament (Polydioxanone), Absorbable Surgical Suture