No Brand XK000708-4

GUDID 00885556868836

GII CR DEEP DISH INSERT W/ JOURNEY LOCK SIZE 0 11MM

Smith & Nephew, Inc.

Uncoated knee tibia prosthesis, polyethylene

• Primary Device ID: 00885556868836
• NIH Device Record Key: dc0001ed-29c4-42a9-bc5e-73d3b526989f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: No Brand
• Version Model Number: XK000708-4
• Catalog Number: XK000708-4
• 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)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	00885556868836 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071071

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

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: 2022-02-10
• Device Publish Date: 2022-02-02

On-Brand Devices [No Brand]

• 00885556717073: SINGLE RETRACTOR WITH FINGER LOOP
• 00885556716939: LOCKING T-HANDLE
• 00885556705131: SHORT OBTURATOR
• 00885556705124: SHORT HALF CANNULA
• 00885556705117: BONE GRAFT PREP TOOL
• 00885556705100: LONG BULLET
• 00885556705094: SHORT BULLET
• 00885556705087: DOUBLE BULLET GLENOID DRILL GUIDE
• 00885556704165: GIGLI SAW PASSER
• 00885556695456: 11'' x 2.4mm Trocar tip passing pin
• 00885556684658: SHORT OBTURATOR
• 00885556684641: SHORT HALF CANNULA
• 00885556684634: BONE GRAFT PREP TOOL
• 00885556684627: LONG BULLET
• 00885556684610: SHORT BULLET
• 00885556684603: DOUBLE BULLET GLENOID DRILL GUIDE
• 00885556675212: SLIDING BLOCK
• 00885556675205: SUBSCAP SPREADER
• 00885556675199: SUTURE TENSIONER
• 00885556675182: TISSUE RETRACTOR STRAIGHT
• 00885556675175: TISSUE RETRACTOR BEND
• 00885556667491: MODIFIED TROCAR TIP PASSING PINS
• 00885556666708: 2 DEGREE VARUS VALGUS RECUT BLOCK
• 00885556666685: 2MM RECUT BLOCK
• 00885556664513: LONG T8 DRIVER WITH AO Quick Connect
• 00885556664506: LONG T7 DRIVER WITH AO Quick Connect
• 00885556662809: 2.5CM COBRA RETRACTOR
• 00885556662793: LARGE BENT HOMANN RETRACTOR
• 00885556662786: RIGHT ACETABULAR ELEVATOR RETRACTOR
• 00885556662779: LEFT ACETABULAR ELEVATOR RETRACTOR
• 00885556662175: GUIDE PIN SLEEVE - SHORT STRAIGHT HANDLE
• 00885556659335: RIGHT DUAL OFFSET BOX OSTEOTOME
• 00885556659328: LEFT DUAL OFFSET BOX OSTEOTOME
• 00885556659311: RAT TAIL RASP
• 00885556658673: 4.0MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 50MM
• 00885556658666: 4.0MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 48MM
• 00885556658659: 4.0MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 46MM
• 00885556658642: 4.0MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 44MM
• 00885556658635: 4.0MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 42MM
• 00885556658628: 4.0MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 40MM
• 00885556658611: 4.0MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 38MM
• 00885556658604: 4.0MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 36MM
• 00885556658598: 4.0MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 34MM
• 00885556658581: 4.0MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 32MM
• 00885556658574: 4.0MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 30MM
• 00885556658550: 4.0MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 50MM
• 00885556658543: 4.0MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 48MM
• 00885556658536: 4.0MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 46MM
• 00885556658529: 4.0MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 44MM
• 00885556658512: 4.0MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 42MM