HEALICOIL 72203952

GUDID 00885554031713

HEALICOIL RG DILATOR 5.5MM DISPOSABLE

Smith & Nephew, Inc.

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• Primary Device ID: 00885554031713
• NIH Device Record Key: a3e08a2e-e602-4d5e-a63e-acb8d34501ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEALICOIL
• Version Model Number: 72203952
• Catalog Number: 72203952
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• 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: 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)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• 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
• 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
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885554031713 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123393

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: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-29

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