ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 904-1015

GUDID 03701037313480

STABILITY TRIAL CUP Ø40 + 15 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15

FX SOLUTIONS

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03701037313480
• NIH Device Record Key: 5193cd12-6974-43d3-a094-c22fa51bdb71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Version Model Number: 904-1015
• Catalog Number: 904-1015
• Company DUNS: 263076196
• Company Name: FX SOLUTIONS
• 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: 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701037313480 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[03701037313480]

Moist Heat or Steam Sterilization

[03701037313480]

Moist Heat or Steam Sterilization

[03701037313480]

Moist Heat or Steam Sterilization

[03701037313480]

Moist Heat or Steam Sterilization

[03701037313480]

Moist Heat or Steam Sterilization

[03701037313480]

Moist Heat or Steam Sterilization

[03701037313480]

Moist Heat or Steam Sterilization

[03701037313480]

Moist Heat or Steam Sterilization

[03701037313480]

Moist Heat or Steam Sterilization

[03701037313480]

Moist Heat or Steam Sterilization

[03701037313480]

Moist Heat or Steam Sterilization

[03701037313480]

Moist Heat or Steam Sterilization

[03701037313480]

Moist Heat or Steam Sterilization

[03701037313480]

Moist Heat or Steam Sterilization

[03701037313480]

Moist Heat or Steam Sterilization

[03701037313480]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-10-08
• Device Publish Date: 2020-05-20

On-Brand Devices [ORTHOPEDIC MANUAL SURGICAL INSTRUMENT]

• 03701037313558: STABILITY TRIAL CUP FOR BOACH Ø32 +18 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15
• 03701037313541: STABILITY TRIAL CUP FOR BOACH Ø32 +15 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15
• 03701037313534: STABILITY TRIAL CUP FOR BOACH Ø32 +12 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15
• 03701037313527: STABILITY TRIAL CUP FOR BOACH Ø32+9 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15
• 03701037313510: STABILITY TRIAL CUP FOR BOACH Ø32+6 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15
• 03701037313503: STABILITY TRIAL CUP FOR BOACH Ø32+3 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15
• 03701037313497: STABILITY TRIAL CUP Ø40 + 18 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15
• 03701037313480: STABILITY TRIAL CUP Ø40 + 15 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15
• 03701037313473: STABILITY TRIAL CUP Ø40 + 12 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15
• 03701037313466: STABILITY TRIAL CUP Ø36 + 18 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15
• 03701037313459: STABILITY TRIAL CUP Ø36 + 15 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15
• 03701037313442: STABILITY TRIAL CUP Ø36 + 12 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15
• 03701037313138: STANDARD TRIAL HUMERAL CUP 135/145° Ø40 +18 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15
• 03701037313121: STANDARD TRIAL HUMERAL CUP 135/145° Ø40 +15 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15
• 03701037313114: STANDARD TRIAL HUMERAL CUP 135/145° Ø40 +12 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15
• 03701037313107: STANDARD TRIAL HUMERAL CUP 135/145° Ø36 +18 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15
• 03701037313091: STANDARD TRIAL HUMERAL CUP 135/145° Ø36 +15 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15
• 03701037313084: STANDARD TRIAL HUMERAL CUP 135/145° Ø36 +12 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15
• 03701037313077: STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +18 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15
• 03701037313060: STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15
• 03701037313053: STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +12
• 03701037312735: GLENOID RESURFACING REAMER Ø43 mm / FX
• 03701037312179: SPIKED PROTECTOR Ø 41mm
• 03701037312162: SPIKED PROTECTOR Ø 46mm
• 03701037317723: HOLLOW GLENOID K-WIRE GUIDE + TEMPLATE SIZE L
• 03701037317716: HOLLOW GLENOID K-WIRE GUIDE + TEMPLATE SIZE M
• 03701037317709: HOLLOW GLENOID K-WIRE GUIDE + TEMPLATE SIZE S
• 03701037317693: HOLLOW GLENOID K-WIRE GUIDE + TEMPLATE SIZE XS
• 03701037317686: 40/16 HUMELOCK REVERSED BROACH WITH RADIUS
• 03701037317679: 40/14 HUMELOCK REVERSED BROACH WITH RADIUS
• 03701037317662: 40/12 HUMELOCK REVERSED BROACH WITH RADIUS
• 03701037317655: 36/14 HUMELOCK REVERSED BROACH WITH RADIUS
• 03701037317648: 36/12 HUMELOCK REVERSED BROACH WITH RADIUS
• 03701037317631: 36/10 HUMELOCK REVERSED BROACH WITH RADIUS
• 03701037317624: 32/12 HUMELOCK REVERSED BROACH WITH RADIUS
• 03701037317617: 32/10 HUMELOCK REVERSED BROACH WITH RADIUS
• 03701037317600: 32/08 HUMELOCK REVERSED BROACH WITH RADIUS
• 03701037317594: STANDARD TRIAL FIXED CUP FOR BROACH Ø40 +18
• 03701037317587: STANDARD TRIAL FIXED CUP FOR BROACH Ø40 +15
• 03701037317570: STANDARD TRIAL FIXED CUP FOR BROACH Ø40 +12
• 03701037317563: STANDARD TRIAL FIXED CUP FOR BROACH Ø40 +9
• 03701037317556: STANDARD TRIAL FIXED CUP FOR BROACH Ø40 +6
• 03701037317549: STANDARD TRIAL FIXED CUP FOR BROACH Ø40 +3
• 03701037317532: STANDARD TRIAL FIXED CUP FOR BROACH Ø36 +18
• 03701037317525: STANDARD TRIAL FIXED CUP FOR BROACH Ø36 +15
• 03701037317518: STANDARD TRIAL FIXED CUP FOR BROACH Ø36 +12
• 03701037317501: STANDARD TRIAL FIXED CUP FOR BROACH Ø36 +9
• 03701037317495: STANDARD TRIAL FIXED CUP FOR BROACH Ø36 +6
• 03701037317488: STANDARD TRIAL FIXED CUP FOR BROACH Ø36 +3
• 03701037317471: STANDARD TRIAL FIXED CUP FOR BROACH Ø32 +18