SURGICEL 1953S

GUDID 30705031468126

Absorbable Hemostat (oxidized regenerated cellulose)

Ethicon Sàrl

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• Primary Device ID: 30705031468126
• NIH Device Record Key: a4769909-869c-4869-8534-39809a08f062
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURGICEL
• Version Model Number: 1953S
• Catalog Number: 1953S
• Company DUNS: 480920383
• Company Name: Ethicon Sàrl
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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
• 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
• 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
• 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
• 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
• 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

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031468122 [Primary]
GS1	30705031468126 [Package]; Contains: 10705031468122; Package: CASE [12 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-23
• Device Publish Date: 2023-05-15

On-Brand Devices [SURGICEL]

• 20705031003061: SURGICEL Absorbable Hemostats (oxidized regenerated cellulose)
• 20705031003030: SURGICEL Absorbable Hemostats (oxidized regenerated cellulose)
• 20705031003023: SURGICEL Absorbable Hemostats (oxidized regenerated cellulose)
• 20705031003016: SURGICEL Absorbable Hemostats (oxidized regenerated cellulose)
• 30705031468133: Absorbable Hemostat (oxidized regenerated cellulose)
• 30705031468126: Absorbable Hemostat (oxidized regenerated cellulose)
• 30705031468119: Absorbable Hemostat (oxidized regenerated cellulose)
• 30705031468102: Absorbable Hemostat (oxidized regenerated cellulose)