ACUFEX 72205102

GUDID 20885556714113

ACUFEX ACCESS POSITIONING KIT

Smith & Nephew, Inc.

Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner

• Primary Device ID: 20885556714113
• NIH Device Record Key: 35d84300-a815-4f0c-8796-f43b963d6ed5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACUFEX
• Version Model Number: 72205102
• Catalog Number: 72205102
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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)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	00885556714119 [Primary]
GS1	20885556714113 [Package]; Contains: 00885556714119; Package: BX [6 Units]; In Commercial Distribution

FDA Product Code

• KQZ: COMPONENT, TRACTION, NON-INVASIVE

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: 2018-12-17
• Device Publish Date: 2018-11-16

On-Brand Devices [ACUFEX]

• 00885556727089: FEMORAL PCL AIMER
• 00885556727072: TIBIA PCL AIMER ¿RIGHT
• 00885556727065: TIBIAL PCL AIMER - LEFT
• 00885556715505: PIVOTING AIMER ASSEMBLY
• 00885556715130: ACUFEX ACCESS CART
• 00885556715123: ACUFEX ACCESS LATERAL TRACTION BOOM
• 00885556715116: ACUFEX ACCESS POSITIONING SYSTEM
• 20885556714120: ACUFEX ACCESS ADVANCED POSITIONING KIT
• 20885556714113: ACUFEX ACCESS POSITIONING KIT
• 00885556708552: ACUFEX EXTRA ARTICULAR RECON SYSTEM TRAY
• 00885556708545: ACUFEX EXTRA ARTICULAR RECONSTRUCTION OFFSET GUIDE
• 00885556708538: ACUFEX EXTRA ARTICULAR RECONSTRUCTION FEMORAL GUIDE
• 00885556708521: ACUFEX EXTRA-ARTICULAR RECONSTRUCTION TIBIAL GUIDE
• 00885556708514: ACUFEX EXTRA ARTICULAR RECONSTRUCTION FIBULAR GUIDE
• 00885556707654: ACUFEX EXTRA ARTICULAR SHORT BULLET
• 00885556707647: ACUFEX EXTRA ARTICULAR LONG BULLET
• 00885556668764: MODIFIED CLANCY ACL GUIDE
• 00885556668757: MODIFIED CLANCY ACL GUIDE
• 00885556658062: SOD PORTAL STICK 4mm
• 00885556608616: REFURB PUNCH SUTURE ACUFEX
• 00885556604540: O*REFURB SMALL JOINT GRASPER
• 00885556602164: SOD ACUFEX DIR 4 POINT BULLET 4.5MM
• 00885556600238: MTO PROBE STRAIGHT - PURCHASED
• 00885556568903: REFURBSTRTR.ACUFEX SCREW
• 00885556541012: MTO AIMERTIP SHORT DIRECTOR
• 00885556533321: ACUFEX¿IRECTOR MRR Drill Guide Handle
• 00885556533314: ACUFEX¿IRECTOR MRR Angled Bullet
• 00885556504604: REFURB AIMER TIBIAL PCL
• 00885554038729: MTO TIBIAL ROUTER 9MM
• 00885554030518: ACUFEX TUNNEL GAUGE
• 00885554028508: AWL INSERTION SITE MARKING 45 DEGREES
• 00885554028003: TRAY PINPOINT AACL SGL BNDL GUIDE
• 00885554027938: TRAY PINPOINT AACL GUIDE SYSTEM
• 00885554026917: ACUFEX PINPOINT BULLET 4 POINT - 6.5
• 00885554026900: ACUFEX PINPOINT INSIDE-OUT HANDLE
• 00885554026894: ACUFEX PINPOINT OUTSIDE-IN AMR ARM RT
• 00885554026887: ACUFEX PINPOINT OUTSIDE-IN AMR ARM LEFT
• 00885554026870: ACUFEX PINPOINT DBL BNDL BLT SUPRT 6-7MM
• 00885554026863: ACUFEX PINPOINT DBL BNDL BLT SUPRT 5-7MM
• 00885554026856: ACUFEX PINPOINT DBL BNDL BLT SUPRT 5-6MM
• 00885554026849: ACUFEX PINPOINT DBL BNDL BLT SUPRT 7-8MM
• 00885554026832: ACUFEX PINPOINT DBL BNDL BULL SPT 6-8MM
• 00885554026825: ACUFEX PINPOINT SINGLE BUNDLE GUIDE 10MM
• 00885554026818: ACUFEX PINPOINT SINGLE BUNDLE GUIDE 9MM
• 00885554026801: ACUFEX PINPOINT SINGLE BUNDLE GUIDE 8MM
• 00885554026795: ACUFEX PINPOINT SNGL BNDL GD 7MM
• 00885554026788: ACUFEX PINPOINT SINGLE BUNDLE GUIDE 6MM
• 00885554026771: ACUFEX PINPOINT DBL BNDL GD RIGHT 7-8MM
• 00885554026764: ACUFEX PINPOINT DBL BNDL GD RIGHT 6-8MM
• 00885554026757: ACUFEX PINPOINT DBL BNDL GD RIGHT 6-7MM