RAM® COR-SUTURE® QUICK LOAD®

GUDID 10850200006435

RAM® COR-SUTURE® QUICK LOAD® SINGLES with PTFE Pledget - 2-0 Polyester, Sterile, Synthetic, Non-Absorbable, Coated, Braided, Surgical Suture, USP, 3.0 Metric, 38", 97 cm, 2 Ferrules, White, PTFE pledget

LSI Solutions, Inc.

Polyester suture, non-bioabsorbable, multifilament

• Primary Device ID: 10850200006435
• NIH Device Record Key: eac13caa-a47c-4f9a-8007-e384fe0baed9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAM® COR-SUTURE® QUICK LOAD®
• Version Model Number: 022047
• Company DUNS: 603420183
• Company Name: LSI Solutions, Inc.
• 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: 866-575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com

Device Dimensions

• Outer Diameter: 0.32 Millimeter
• Outer Diameter: 0.32 Millimeter
• Outer Diameter: 0.32 Millimeter
• Outer Diameter: 0.32 Millimeter
• Outer Diameter: 0.32 Millimeter
• Outer Diameter: 0.32 Millimeter
• Outer Diameter: 0.32 Millimeter
• Outer Diameter: 0.32 Millimeter
• Outer Diameter: 0.32 Millimeter
• Outer Diameter: 0.32 Millimeter
• Outer Diameter: 0.32 Millimeter
• Outer Diameter: 0.32 Millimeter
• Outer Diameter: 0.32 Millimeter
• Outer Diameter: 0.32 Millimeter
• Outer Diameter: 0.32 Millimeter
• Outer Diameter: 0.32 Millimeter
• Outer Diameter: 0.32 Millimeter
• Outer Diameter: 0.32 Millimeter
• Outer Diameter: 0.32 Millimeter
• Outer Diameter: 0.32 Millimeter
• Outer Diameter: 0.32 Millimeter
• Outer Diameter: 0.32 Millimeter
• Outer Diameter: 0.32 Millimeter
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch
• Length: 38 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 500 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 500 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 500 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 260 Degrees Celsius
• Storage Environment Temperature: Between 0 and 500 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 260 Degrees Celsius
• Storage Environment Temperature: Between 0 and 500 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 260 Degrees Celsius
• Storage Environment Temperature: Between 0 and 500 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 260 Degrees Celsius
• Storage Environment Temperature: Between 0 and 500 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 260 Degrees Celsius
• Storage Environment Temperature: Between 0 and 500 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 260 Degrees Celsius
• Storage Environment Temperature: Between 0 and 500 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 260 Degrees Celsius
• Storage Environment Temperature: Between 0 and 500 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 260 Degrees Celsius
• Storage Environment Temperature: Between 0 and 500 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 260 Degrees Celsius
• Storage Environment Temperature: Between 0 and 500 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 260 Degrees Celsius
• Storage Environment Temperature: Between 0 and 500 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 260 Degrees Celsius
• Storage Environment Temperature: Between 0 and 500 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 260 Degrees Celsius
• Storage Environment Temperature: Between 0 and 500 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 260 Degrees Celsius
• Storage Environment Temperature: Between 0 and 500 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 260 Degrees Celsius
• Storage Environment Temperature: Between 0 and 500 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 260 Degrees Celsius
• Storage Environment Temperature: Between 0 and 500 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 260 Degrees Celsius
• Storage Environment Temperature: Between 0 and 500 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 260 Degrees Celsius
• Storage Environment Temperature: Between 0 and 500 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 260 Degrees Celsius
• Storage Environment Temperature: Between 0 and 500 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 260 Degrees Celsius
• Storage Environment Temperature: Between 0 and 500 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 260 Degrees Celsius
• Storage Environment Temperature: Between 0 and 500 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 260 Degrees Celsius
• Storage Environment Temperature: Between 0 and 500 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 260 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850200006438 [Primary]
GS1	10850200006435 [Package]; Contains: 00850200006438; Package: Box / Inner Pack [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160529

FDA Product Code

• GAS: Suture, Nonabsorbable, Synthetic, Polyester

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-06-02

On-Brand Devices [RAM® COR-SUTURE® QUICK LOAD®]

• 10850200006435: RAM® COR-SUTURE® QUICK LOAD® SINGLES with PTFE Pledget - 2-0 Polyester, Sterile, Synthetic, N
• 10850200006404: RAM® COR-SUTURE® QUICK LOAD® Pledgeted Surgical Suture 6-Tray - 2-0 Polyester, Sterile, Synth
• 10850200006824: RAM® COR-SUTURE® QUICK LOAD® 5MM, PLEDGETED SURGICAL SUTURE 6-TRAY - 2-0 Polyester
• 10850200006817: RAM® COR-SUTURE® QUICK LOAD® SINGLES, 5MM 2-0 Polyester, Green/White Striped
• 10850200006800: RAM® COR-SUTURE® QUICK LOAD® SINGLES, 5MM 2-0 Polyester, White
• 10850200006794: RAM® COR-SUTURE® QUICK LOAD® SINGLES 5MM, 2-0 Polyester, Green
• 10850200006787: RAM® COR-SUTURE® QUICK LOAD® SINGLES 5MM, PLEDGETED 2-0 Polyester, Green/White Striped
• 10850200006770: RAM® COR-SUTURE® QUICK LOAD® SINGLES 5MM, PLEDGETED 2-0 Polyester, White
• 10850200006763: RAM® COR-SUTURE® QUICK LOAD® SINGLES 5MM, PLEDGETED 2-0 Polyester, Green
• 10850200006480: RAM® COR-SUTURE® QUICK LOAD® SINGLES 2-0 Polyester, Green/White Striped
• 10850200006473: RAM® COR-SUTURE® QUICK LOAD® SINGLES 2-0 Polyester, Green
• 10850200006466: RAM® COR-SUTURE® QUICK LOAD® SINGLES 2-0 Polyester, White
• 10850200006459: RAM® COR-SUTURE® QUICK LOAD® SINGLES Pledgeted 2-0 Polyester, Green/White Striped
• 10850200006442: RAM® COR-SUTURE® QUICK LOAD® SINGLES with PTFE Pledget - 2-0 Polyester, Green