HEALICOIL / ULTRABRAID 72203706

GUDID 00885554031416

HEALICOIL RG SA 5.5MM W/2 UB-BL CBRD BL

Smith & Nephew, Inc.

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 00885554031416
• NIH Device Record Key: db6d44ec-084d-4c43-8075-45968d0dc107
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEALICOIL / ULTRABRAID
• Version Model Number: 72203706
• Catalog Number: 72203706
• Company DUNS: 109903521
• Company Name: Smith & Nephew, 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: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885554031416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151105

FDA Product Code

• MAI: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-21
• Device Publish Date: 2016-01-10

On-Brand Devices [HEALICOIL / ULTRABRAID]

• 00885554031416: HEALICOIL RG SA 5.5MM W/2 UB-BL CBRD BL
• 00885554030860: HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK
• 00885554026313: HEALICOIL SA PK 5.5MM W/3 UB-BL CBBL LT
• 00885554026306: HEALICOIL SA PK 5.5MM W/2 UB-BL CBRD BL
• 03596010657862: HEALICOIL SA PK 4.5MM W/2 UB-BL CBRD BL