RAM® COR-SUTURE® QUICK LOAD®

GUDID 10850200006404

RAM® COR-SUTURE® QUICK LOAD® Pledgeted Surgical Suture 6-Tray - 2-0 Polyester, Sterile, Synthetic, Non-Absorbable, Coated, Braided, Surgical Suture, USP, 3.0 Metric, 38", 97 cm, 2 Ferrules, PTFE pledget, Green (3), White (3) Each sterile package contains a tray of (6) 2-0 Polyester Surgical Sutures, (3.0 Metric), 2 Ferrules, PTFE Pledget, 38" (97 cm), (3) Green and (3) White.

LSI Solutions, Inc.

Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament

• Primary Device ID: 10850200006404
• NIH Device Record Key: 0684cfd1-a0c3-4946-b7db-e3c4a7525203
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAM® COR-SUTURE® QUICK LOAD®
• Version Model Number: 022090
• Company DUNS: 603420183
• Company Name: LSI Solutions, Inc.
• Device Count: 6
• 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 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
• Storage Environment Temperature: Between 0 and 500 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850200006407 [Primary]
GS1	00850200006414 [Unit of Use]
GS1	10850200006404 [Package]; Contains: 00850200006407; Package: Box/Inner Pack [6 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