ECHELON 71368019

GUDID 03596010329615

ECHELON 190MM STRAIGHT STEM TRIAL SIZE 19

Smith & Nephew, Inc.

Femoral stem prosthesis trial

• Primary Device ID: 03596010329615
• NIH Device Record Key: fbd260c3-ee4a-4e45-ba79-6a90e343455a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECHELON
• Version Model Number: 71368019
• Catalog Number: 71368019
• 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: false
• 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
• 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	03596010329615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123598

FDA Product Code

• JDG: Prosthesis, hip, femoral component, cemented, metal

Sterilization

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

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

[03596010329615]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-10-11
• Device Publish Date: 2015-08-30

On-Brand Devices [ECHELON]

• 00885556648759: PROXIMAL REAMER SLEEVE
• 00885556617885: PROXIMAL REAMER SLEEVE
• 00885556278611: ECH PRIM FULLCOAT SZ 19 HIGHOFFSET
• 00885556278567: ECH PRIM FULLCOAT SZ 18 HIGHOFFSET
• 00885556112762: ECHELON TITANIUM PRIMARY STD OFFSET 10-12 TPR S 11
• 00885556112755: ECHELON TITANIUM PRIMARY HIGH OFFSET 10-12 TPR S10
• 00885556056745: ECHELON PRIMARY STEM PC HA STD 12/14 TAPER SZ 17
• 00885556056622: ECHELON PRIMARY STEM PC HA STD 12/14 TAPER SZ 14
• 00885556056370: ECHELON PRIMARY STEM PC HA STD 12/14 TAPER SZ 13
• 00885556056363: ECHELON PRIMARY STEM PC HA HO 12/14 TAPER SZ 15
• 00885556056219: ECHELON PRIMARY STEM PC HA STD 12/14 TAPER SZ 16
• 00885556056141: ECHELON PRIMARY STEM PC HA STD 12/14 TAPER SZ 12
• 00885556056097: ECHELON PRIMARY STEM PC HA HO 12/14 TAPER SZ 14
• 00885556055960: ECHELON PRIMARY STEM PC HA HO 12/14 TAPER SZ 17
• 00885556055922: ECHELON PRIMARY STEM PC HA HO 12/14 TAPER SZ 13
• 00885556055724: ECHELON PRIMARY STEM PC HA STD 12/14 TAPER SZ 15
• 00885556055694: ECHELON PRIMARY STEM PC HA HO 12/14 TAPER SZ 12
• 00885556055502: ECHELON PRIMARY STEM PC HA HO 12/14 TAPER SZ 16
• 00885556052501: ECH HA PC 260MM BWD 15MM CALCAR 17R
• 00885556052495: ECH HA PC 260MM BWD15MM CALCAR 12R
• 00885556052464: ECH HA PC 260MM BWD 15MM CALCAR 20R
• 00885556052440: ECH HA PC 260MM BOWED SZ 13 RT
• 00885556052433: ECH PRM FEM COMP STD 12/14 SZ 17 CLRLS
• 00885556052402: ECH HA PC 260MM BOWED SZ15 LT
• 00885556052396: ECH HA PC 260MM BWD 15MM CALCAR 18L
• 00885556052266: ECH HA PC 260MM BOWED SZ 14 LT
• 00885556052181: ECH HA PC 260MM BWD 15MM CALCAR 19R
• 00885556052136: ECH HA PC 260MM BWD15MM CALCAR 16R
• 00885556052129: ECH HA PC 260MM BWD 15MM CALCAR 14L
• 00885556052112: ECH HA PC 260MM BOWED SZ 18 RT
• 00885556052105: ECH HA PC 260MM BOWED SZ 12 RT
• 00885556052082: ECH PRM FEM COMP HO 12/14 SZ 19 CLRLS
• 00885556052075: ECH HA PC 260MM BWD 15MM CALCAR 17L
• 00885556052068: ECH PRIM FEM COMP STD 12/14 S14 CLRLS
• 00885556052013: ECH HA PC 260MM BWD 15MM CALCAR 13L
• 00885556051917: ECH PRM FEM COMP HO 12/14 SZ 18 CLRLS
• 00885556051863: ECH HA PC 260MM BOWED SZ 19 RT
• 00885556051825: ECH PRIM FEM COMP HO 12/14 S14 CLRLS
• 00885556051818: ECH HA PC 260MM BWD 15MM CALCAR 12L
• 00885556051719: ECH HA PC 260MM BOWED SZ 17 RT
• 00885556051672: ECH HA PC 260MM BOWED SZ 18 LT
• 00885556051627: ECH HA PC 260MM BOWED SZ 20 LT
• 00885556051580: ECH PRIM FEM COMP HO 12/14 S13 CLRLS
• 00885556051450: ECH HA PC 260MM BWD 15MM CALCAR 20L
• 00885556051443: ECH PRIM FEM COMP STD 12/14 S13 CLRLS
• 00885556051351: ECH HA PC 260MM BWD 15MM CALCAR 15R
• 00885556051276: ECH PRM FEM COMP HO 12/14 SZ 17 CLRLS
• 00885556051214: ECH HA PC 260MM BWD 15MM CALCAR 19L
• 00885556051184: ECH PRM FEM COMP STD 12/14 S12 CLRLS
• 00885556051153: ECH HA PC 260MM BOWED SZ 19 LT