HEALICOIL 72205385

GUDID 00885556885345

HEALICOIL REGENESORB 4.75MM SUTURE ANCHOR WITH TWO MINITAPE SUTURES (BLUE, COBRAID WHITE)

Smith & Nephew, Inc.

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 00885556885345
• NIH Device Record Key: 4034773a-58bf-4d8f-a6c1-c78d7b9de5ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEALICOIL
• Version Model Number: 72205385
• Catalog Number: 72205385
• Company DUNS: 045483575
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556885345 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-21
• Device Publish Date: 2023-09-13

On-Brand Devices [HEALICOIL]

• 00885554032130: HEALICOIL PK 4.5MM W/ ULTRA TAPE CBRD
• 00885554032123: HEALICOIL PK 4.5MM W/ ULTRA TAPE BLUE
• 00885554032116: HEALICOIL PK 5.5MM W/ UB2-BL UTP CBRD
• 00885554032109: HEALICOIL PK 5.5MM W/ UB2-CBR BLK UTP BL
• 00885554031713: HEALICOIL RG DILATOR 5.5MM DISPOSABLE
• 00885554031706: HEALICOIL RG DILATOR 4.75MM DISPOSABLE
• 00885554030877: HEALICOIL RG DILATOR 5.5MM REUSABLE
• 00885554030501: HEALICOIL RG DILATOR 4.75MM REUSABLE
• 00885554030310: HEALICOIL RG SA 4.75MM W/2 UB-BL CBRD BL
• 00885554026016: DRILL 4.5MM SPADE TIP HEALICOIL SA
• 00885554026009: DRILL 3.5MM SPADE TIP HEALICOIL SA
• 00885554025828: AWL-DILATOR 4.5MM HEALICOIL
• 00885554025811: AWL-DILATOR 5.5MM HEALICOIL
• 00885556768617: DRILL 4.75MM HEALICOIL KNOTLESS
• 00885556767351: HEALICOIL KNOTLESS PK ST
• 00885556767337: HEALICOIL KNOTLESS PK NST
• 00885556767320: HEALICOIL KNOTLESS RG ST
• 00885556767146: HEALICOIL KNOTLESS RGNST
• 00885556885376: HEALICOIL REGENESORB 5.5MM SUTURE ANCHOR WITH THREE MINITAPE
• 00885556885369: HEALICOIL REGENESORB 5.5MM SUTURE ANCHOR WITH TWO MINITAPE S
• 00885556885352: HEALICOIL REGENESORB 4.75MM SUTURE ANCHOR WITH THREE MINITAP
• 00885556885345: HEALICOIL REGENESORB 4.75MM SUTURE ANCHOR WITH TWO MINITAPE
• 00885556885338: HEALICOIL PK 5.5MM SUTURE ANCHOR WITH THREE MINITAPE SUTURES
• 00885556885321: HEALICOIL PK 5.5MM SUTURE ANCHOR WITH TWO MINITAPE SUTURES (
• 00885556885314: HEALICOIL PK 4.5MM SUTURE ANCHOR WITH TWO MINITAPE SUTURES (
• 00885556885611: HEALICOIL PK SUTURE ANCHOR WITH NEEDLES ULTRATAPE BLUE COBRA
• 00885556885604: HEALICOIL PK SUTURE ANCHOR WITH NEEDLES ULTRATAPE BLUE