Peri-Loc XT001085-1

GUDID 00885556703809

SS FLAT INFERIOR DISTAL CLAVICLE PLATE 6H

Smith & Nephew, Inc.

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 00885556703809
• NIH Device Record Key: 32823db0-c7d8-4689-baee-5bc24e0e6e94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Peri-Loc
• Version Model Number: XT001085-1
• Catalog Number: XT001085-1
• 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: false
• 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	00885556703809 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061352

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00885556703809]

Moist Heat or Steam Sterilization

[00885556703809]

Moist Heat or Steam Sterilization

[00885556703809]

Moist Heat or Steam Sterilization

[00885556703809]

Moist Heat or Steam Sterilization

[00885556703809]

Moist Heat or Steam Sterilization

[00885556703809]

Moist Heat or Steam Sterilization

[00885556703809]

Moist Heat or Steam Sterilization

[00885556703809]

Moist Heat or Steam Sterilization

[00885556703809]

Moist Heat or Steam Sterilization

[00885556703809]

Moist Heat or Steam Sterilization

[00885556703809]

Moist Heat or Steam Sterilization

[00885556703809]

Moist Heat or Steam Sterilization

[00885556703809]

Moist Heat or Steam Sterilization

[00885556703809]

Moist Heat or Steam Sterilization

[00885556703809]

Moist Heat or Steam Sterilization

[00885556703809]

Moist Heat or Steam Sterilization

[00885556703809]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-16

On-Brand Devices [Peri-Loc]

• 00885556734179: EXTENDED T8 DRIVER SHAFT
• 00885556734162: EXTENDED T7 DRIVER SHAFT
• 00885556734155: EXTENDED T6 DRIVER SHAFT
• 00885556732397: RIGHT 4.5MM DISTAL FEMUR PLATE TEMPLATE
• 00885556731697: SS FLAT INFERIOR DISTAL CLAVICLE PLATE 10H
• 00885556731680: SS FLAT INFERIOR DISTAL CLAVICLE PLATE 6H
• 00885556728758: T20 NON SELF RETAINING DRIVER
• 00885556728741: T15 NON SELF RETAINING DRIVER
• 00885556725917: LONG T6 DRIVER WITH AO QUICK CONNECT
• 00885556725443: LONG T8 DRIVER WITH AO QUICK CONNECT
• 00885556725436: LONG T7 DRIVER WITH AO QUICK CONNECT
• 00885556720776: SST 4.5MM PUBIC SYMPHYSIS LOCKING PLATE 4H
• 00885556718315: 4.5MM PROXIMAL FEMUR LOCKING PLATE 6H RT 10¿END
• 00885556718308: 4.5MM PROXIMAL FEMUR LOCKING PLATE 4H RT 10¿END
• 00885556718292: PELVIC COMPRESSION DEVICE
• 00885556718278: Ball Spike/Paddle Pelvic Forceps
• 00885556718261: DUAL BALL SPIKE PELVIC FORCEPS
• 00885556717462: 2.7MM VLP DOUBLE DRILL GUIDE
• 00885556717448: SS FLAT INFERIOR DISTAL CLAVICLE PLATE 10H
• 00885556717431: SS FLAT INFERIOR DISTAL CLAVICLE PLATE 6H
• 00885556716236: 4.5MM PROXIMAL FEMUR LOCKING PLATE 4H 130MM RT
• 00885556716229: 4.5MM PROXIMAL FEMUR LOCKING PLATE 4H 130MM RT
• 00885556715598: 4.5MM PROXIMAL FEMUR LOCKING PLATE 9H RT 20¿END
• 00885556715581: 4.5MM PROXIMAL FEMUR LOCKING PLATE 9H RT 10¿END
• 00885556710340: 4.5MM LATERAL DISTAL FEMUR TARGETER - LT
• 00885556710333: 4.5MM LATERAL DISTAL FEMUR TARGETER - RT
• 00885556710272: CUSTOM PELVIC COMPRESSION DEVICE
• 00885556710265: RIB PERIOSTEAL ELEVATOR
• 00885556710258: SPIKED ELEVATOR - ANGLED
• 00885556710241: SPIKED ELEVATOR - STRAIGHT
• 00885556710234: KING TONGS W/ TEETH
• 00885556710227: KING TONGS W/ BALL TIP
• 00885556709443: 2.7MM VLP DOUBLE DRILL GUIDE
• 00885556706565: T25 SCREWDRIVER
• 00885556706558: 3.5MM HEX HEAD SCREWDRIVER
• 00885556703816: SS FLAT INFERIOR DISTAL CLAVICLE PLATE 10H
• 00885556703809: SS FLAT INFERIOR DISTAL CLAVICLE PLATE 6H
• 00885556703625: 2.7MM NEUTRAL LOCKING DRILL GUIDE
• 00885556703519: 3.2MM X 450MM DRILL TIP GUIDE PIN
• 00885556703502: CANNULATED DEPTH GAUGE
• 00885556703496: SPIKE ELEVATOR - STRAIGHT
• 00885556701874: 3.5MM HEX DRIVER
• 00885556699591: RIGHT PROXIMAL HUMERUS PLATE GUIDE
• 00885556699584: LEFT PROXIMAL HUMERUS PLATE GUIDE
• 00885556698471: SPEED NUT
• 00885556694329: 2.7MM VLP DOUBLE DRILL GUIDE
• 00885556687154: LONG LOAD DRILL GUIDE
• 00885556687147: LONG NEUTRAL DRILL GUIDE
• 00885556686904: PELVIC INSTRUMENT TRAY LID
• 00885556686898: PELVIC INSTRUMENT INNER TRAY