ICONIX 3910-500-412

GUDID 37613327283458

ICONIX 1 NEEDLES WITH INTELLIBRAID TECHNOLOGY, 1.4MM ANCHOR WITH 1 STRAND #2 FORCE FIBER

STRYKER CORPORATION

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 37613327283458
• NIH Device Record Key: bc09e8f8-1833-4d81-9473-ed6fd44cd974
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICONIX
• Version Model Number: 3910500412
• Catalog Number: 3910-500-412
• Company DUNS: 187502109
• Company Name: STRYKER CORPORATION
• 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(866)624-4422
• Email: xx@xx.xx

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327283457 [Primary]
GS1	37613327283458 [Package]; Contains: 07613327283457; Package: pack [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151201

FDA Product Code

• MBI: Fastener, fixation, nondegradable, 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: 2016-09-22

On-Brand Devices [ICONIX]

• 37613327374224: ICONIX SPEED Anchor 2.3mm 3 Strands 1.2mm XBraid TT Suture Tape
• 37613327374217: ICONIX SPEED Anchor 2.3mm 1.2mm and 2.0mm XBraid TT Suture Tape
• 37613327374200: ICONIX SPEED Anchor 2.3mm 2 Strands #2 Force Fiber Suture
• 37613327374194: ICONIX SPEED ANCHOR 2.3MM 2 STRANDS 2.0MM XBRAID TT SUTURE TAPE
• 37613327283465: ICONIX 2 NEEDLES WITH INTELLIBRAID TECHNOLOGY, 2.3MM ANCHOR WITH 2.0MM XBRAID TT
• 37613327283458: ICONIX 1 NEEDLES WITH INTELLIBRAID TECHNOLOGY, 1.4MM ANCHOR WITH 1 STRAND #2 FORCE FIBER
• 37613327283441: ICONIX 1 NEEDLES WITH INTELLIBRAID TECHNOLOGY, 1.4MM ANCHOR WITH 1.2MM XBRAID TT
• 37613327283434: ICONIX 2 NEEDLES WITH INTELLIBRAID TECHNOLOGY, 2.3MM ANCHOR WITH 2 STRANDS #2 FORCE FIBER
• 37613327176934: ICONIX 2 TT WITH INTELLIBRAID TECHNOLOGY, 2.3MM ANCHOR WITH 2 STRANDS 2.0MM XBRAID TT
• 37613327176927: ICONIX 1 TT WITH INTELLIBRAID TECHNOLOGY, 1.4MM ANCHOR WITH 1 STRAND 1.2MM XBRAID TT
• 07613252598718: 2.3MM ICONIX REUSABLE STRAIGHT DRILL
• 07613252506737: 2.3MM ICONIX REUSABLE AWL
• 07613252506720: 1.4MM ICONIX REUSABLE STRAIGHT DRILL
• 07613252506713: 2.3MM ICONIX PENCIL Tip OBTURATOR SHORT
• 07613252506706: 1.4MM ICONIX PENCIL TIP OBTURATOR SHORT
• 07613252506690: 2.3MM ICONIX STRAIGHT GUIDE SHORT
• 07613252506683: 1.4MM ICONIX STRAIGHT GUIDE SHORT
• 37613252450505: 2.3MM ICONIX DISPOSABLE DRILL
• 37613252450499: 1.4MM ICONIX DISPOSABLE DRILL
• 07613252450481: 2.3MM ICONIX TROCAR TIP OBTURATOR
• 07613252450474: 1.4MM ICONIX TROCAR TIP OBTURATOR
• 07613252450467: 2.3MM ICONIX 25¿ SLANT GUIDE
• 07613252450450: 2.3MM ICONIX 12¿ SLANT GUIDE
• 07613252450443: 1.4MM ICONIX 25¿ SLANT GUIDE
• 07613252450436: 1.4MM ICONIX 12¿ SLANT GUIDE
• 07613252450429: 2.3MM ICONIX 25¿ GUIDE
• 07613252450412: 2.3MM ICONIX 12¿ GUIDE
• 07613252450405: 2.3MM ICONIX STRAIGHT GUIDE
• 07613252450399: 1.4MM ICONIX 25¿ GUIDE
• 07613252450382: 1.4MM ICONIX 12¿ GUIDE
• 07613252450375: 1.4MM ICONIX STRAIGHT GUIDE
• 37613252450369: 2.3MM ICONIX 3 ANCHOR W/INTELLIBRAID TECHNOLOGY 3 STRANDS #2 FORCE FIBER
• 37613252450352: 2.3MM ICONIX 25 ANCHOR W/INTELLIBRAID TECHNOLOGY 2 STRANDS #5 FORCE FIBER
• 37613252450345: 2.3MM ICONIX 2 ANCHOR W/INTELLIBRAID TECHNOLOGY 2 STRANDS #2 FORCE FIBER
• 37613252450338: 1.4MM ICONIX 1 ANCHOR W/INTELLIBRAID TECHNOLOGY 1 STRAND #2 FORCE FIBER
• 07613327634693: 3910500581
• 07613327634686: Iconix DC Guide for 1.4mm anchor