PRCT2 926-1020

GUDID 03701037303382

HUMELOCK INSTRUMENT HUMELOCK TRIAL OFFSET MODULAR SYSTEM SIZE 1

FX SOLUTIONS

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03701037303382
• NIH Device Record Key: 12744930-9183-4578-abf7-3a22798cdee8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRCT2
• Version Model Number: 926-1020
• Catalog Number: 926-1020
• Company DUNS: 263076196
• Company Name: FX SOLUTIONS
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701037303382 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143721

FDA Product Code

• HSD: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Sterilization

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

[03701037303382]

Moist Heat or Steam Sterilization

[03701037303382]

Moist Heat or Steam Sterilization

[03701037303382]

Moist Heat or Steam Sterilization

[03701037303382]

Moist Heat or Steam Sterilization

[03701037303382]

Moist Heat or Steam Sterilization

[03701037303382]

Moist Heat or Steam Sterilization

[03701037303382]

Moist Heat or Steam Sterilization

[03701037303382]

Moist Heat or Steam Sterilization

[03701037303382]

Moist Heat or Steam Sterilization

[03701037303382]

Moist Heat or Steam Sterilization

[03701037303382]

Moist Heat or Steam Sterilization

[03701037303382]

Moist Heat or Steam Sterilization

[03701037303382]

Moist Heat or Steam Sterilization

[03701037303382]

Moist Heat or Steam Sterilization

[03701037303382]

Moist Heat or Steam Sterilization

[03701037303382]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-10-07
• Device Publish Date: 2016-12-06

On-Brand Devices [PRCT2]

• 03701037303429: HUMELOCK INSTRUMENT HUMELOCK TRIAL OFFSET MODULAR SYSTEM SIZE 5
• 03701037303412: HUMELOCK INSTRUMENT HUMELOCK TRIAL OFFSET MODULAR SYSTEM SIZE 4
• 03701037303405: HUMELOCK INSTRUMENT HUMELOCK TRIAL OFFSET MODULAR SYSTEM SIZE 3
• 03701037303399: HUMELOCK INSTRUMENT HUMELOCK TRIAL OFFSET MODULAR SYSTEM SIZE 2
• 03701037303382: HUMELOCK INSTRUMENT HUMELOCK TRIAL OFFSET MODULAR SYSTEM SIZE 1
• 03701037303146: PRCT2, PRCT II PLATE TA6V RIGHT 13 HOLES
• 03701037301906: PRCT2, DIAPHYSEAL PLATE TA6V 10 HOLES
• 03701037301890: PRCT2, DIAPHYSEAL PLATE TA6V 9 HOLES
• 03701037301883: PRCT2, DIAPHYSEAL PLATE TA6V 8 HOLES
• 03701037301876: PRCT2, DIAPHYSEAL PLATE TA6V 7 HOLES
• 03701037301869: PRCT2, DIAPHYSEAL PLATE TA6V 6 HOLES
• 03701037301852: DIAPHYSEAL PLATE TA6V 5 HOLES
• 03701037301845: PRCT II HUMERAL PLATE TA6V LEFT, 7 HOLES
• 03701037301838: PRCT II HUMERAL PLATE TA6V LEFT 6 HOLES
• 03701037301807: PRCT2, PRCT II HUMERAL PLATE TA6V LEFT 3 HOLES
• 03701037301791: PRCT2, PRCT II HUMERAL PLATE TA6V RIGHT 7 HOLES
• 03701037301784: PRCT2, PRCT II HUMERAL PLATE TA6V RIGHT 6 HOLES
• 03701037301777: PRCT2, PRCT II HUMERAL PLATE TA6V RIGHT 5 HOLES
• 03701037301760: PRCT2, PRCT II HUMERAL PLATE TA6V RIGHT 4 HOLES
• 03701037301753: PRCT2, PRCT II HUMERAL PLATE TA6V RIGHT 3 HOLES
• 03701037303207: PRCT2, PRCT II PLATE TA6V LEFT 13 HOLES
• 03701037303191: PRCT II PLATE TA6V LEFT 12 HOLES
• 03701037303184: PRCT II PLATE TA6V LEFT 11 HOLES
• 03701037303177: PRCT II PLATE TA6V LEFT 10 HOLES
• 03701037303160: PRCT2, PRCT II PLATE TA6V LEFT 9 HOLES
• 03701037303139: PRCT II PLATE TA6V RIGHT 12 HOLES
• 03701037303115: PRCT II PLATE TA6V RIGHT 11 HOLES
• 03701037303108: PRCT2, PRCT II PLATE TA6V RIGHT 9 HOLES
• 03701037303092: PRCT II HUMERALE PLATE TA6V RIGHT 8 HOLES
• 03701037310939: PRCT II PLATE TA6V LEFT 13 HOLES
• 03701037310922: PRCT II PLATE TA6V LEFT 12 HOLES
• 03701037310915: PRCT II PLATE TA6V LEFT 11 HOLES
• 03701037310908: PRCT II PLATE TA6V LEFT 10 HOLES
• 03701037310892: PRCT II PLATE TA6V LEFT 9 HOLES
• 03701037310885: PRCT II HUMERALE PLATE TA6V LEFT 8 HOLES
• 03701037310861: PRCT II PLATE TA6V RIGHT 12 HOLES
• 03701037310847: PRCT II PLATE TA6V RIGHT 11 HOLES
• 03701037310830: PRCT II HUMERALE PLATE TA6V RIGHT 9 HOLES
• 03701037310823: PRCT II HUMERALE PLATE TA6V RIGHT 8 HOLES
• 03701037301036: HUMELOCK II STEM TA6V SIZE 09 CEMENTLESS TI/HA