epic edge

GUDID 00855019008017

10/0 BL Mono Nylon, 10 cm length, 3/8 cir Spatula Ndl, Single Arm (single device)

R.K. MANUFACTURING CORPORATION OF CONNECTICUT

Nylon suture, non-bioabsorbable, monofilament

• Primary Device ID: 00855019008017
• NIH Device Record Key: b59111d5-8129-4aa3-bfe9-ada621ccbe01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: epic edge
• Version Model Number: N2673
• Company DUNS: 116162108
• Company Name: R.K. MANUFACTURING CORPORATION OF CONNECTICUT
• 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 203-797-8700
• Email: alabarre@rkmcorp.com
• Phone: 203-797-8700
• Email: alabarre@rkmcorp.com
• Phone: 203-797-8700
• Email: alabarre@rkmcorp.com
• Phone: 203-797-8700
• Email: alabarre@rkmcorp.com
• Phone: 203-797-8700
• Email: alabarre@rkmcorp.com
• Phone: 203-797-8700
• Email: alabarre@rkmcorp.com
• Phone: 203-797-8700
• Email: alabarre@rkmcorp.com
• Phone: 203-797-8700
• Email: alabarre@rkmcorp.com
• Phone: 203-797-8700
• Email: alabarre@rkmcorp.com
• Phone: 203-797-8700
• Email: alabarre@rkmcorp.com
• Phone: 203-797-8700
• Email: alabarre@rkmcorp.com
• Phone: 203-797-8700
• Email: alabarre@rkmcorp.com

Device Dimensions

• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 73 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855019008017 [Primary]
GS1	10855019008014 [Package]; Package: Box [12 Units]; In Commercial Distribution

FDA Product Code

• GAR: Suture, Nonabsorbable, Synthetic, Polyamide

Sterilization

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

[00855019008017]

Ethylene Oxide

[00855019008017]

Ethylene Oxide

[00855019008017]

Ethylene Oxide

[00855019008017]

Ethylene Oxide

[00855019008017]

Ethylene Oxide

[00855019008017]

Ethylene Oxide

[00855019008017]

Ethylene Oxide

[00855019008017]

Ethylene Oxide

[00855019008017]

Ethylene Oxide

[00855019008017]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-06-15

On-Brand Devices [epic edge]

• 00855019008031: 10/0 BL Mono Nylon, 30 cm length, 3/8 cir Spatula Ndl, Double Arm (single device)
• 00855019008024: 10/0 BL Mono Nylon, 30 cm length, 1/2 cir Spatula Ndl, Double Arm (single device)
• 00855019008017: 10/0 BL Mono Nylon, 10 cm length, 3/8 cir Spatula Ndl, Single Arm (single device)
• 00855019008000: 10/0 BL Mono Nylon, 10 cm length, 1/2 cir Spatula Ndl, Single Arm (single device)