ARROW Short Stem Humeral System

GUDID 03661489721120

FOURNITURES HOSPITALIERES INDUSTRIE

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 03661489721120
• NIH Device Record Key: 058dffa8-ec21-40f7-97db-921173b5c12f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARROW Short Stem Humeral System
• Version Model Number: 272112- SHOULDER UNIVERSAL TRAY
• Company DUNS: 261839898
• Company Name: FOURNITURES HOSPITALIERES INDUSTRIE
• 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: true
• 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	03661489721120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202024

FDA Product Code

• PHX: Shoulder Prosthesis, Reverse Configuration

Sterilization

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

[03661489721120]

Moist Heat or Steam Sterilization

[03661489721120]

Moist Heat or Steam Sterilization

[03661489721120]

Moist Heat or Steam Sterilization

[03661489721120]

Moist Heat or Steam Sterilization

[03661489721120]

Moist Heat or Steam Sterilization

[03661489721120]

Moist Heat or Steam Sterilization

[03661489721120]

Moist Heat or Steam Sterilization

[03661489721120]

Moist Heat or Steam Sterilization

[03661489721120]

Moist Heat or Steam Sterilization

[03661489721120]

Moist Heat or Steam Sterilization

[03661489721120]

Moist Heat or Steam Sterilization

[03661489721120]

Moist Heat or Steam Sterilization

[03661489721120]

Moist Heat or Steam Sterilization

[03661489721120]

Moist Heat or Steam Sterilization

[03661489721120]

Moist Heat or Steam Sterilization

[03661489721120]

Moist Heat or Steam Sterilization

[03661489721120]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-08
• Device Publish Date: 2023-04-28

On-Brand Devices [ARROW Short Stem Humeral System ]

• 03661489712265: 271226- ARROW EXTRACTEUR DE METAPHYSE
• 03661489712258: 271225- ARROW IMPACTEUR DE PINS
• 03661489712241: 271224- ARROW OSTEOTOME 4MM
• 03661489712234: 271223- ARROW DIAPASON
• 03661489711459: 271145- ARROW PREHENSEUR POUR METAPHYSE
• 03661489711442: 271144- ARROW TOURNEVIS DE SERRAGE
• 03661489711435: 271143- ARROW DIAPHYSE D'ESSAI D16
• 03661489711428: 271142- ARROW DIAPHYSE D'ESSAI D14
• 03661489711411: 271141- ARROW DIAPHYSE D'ESSAI D12
• 03661489711404: 271140- ARROW DIAPHYSE D'ESSAI D10
• 03661489711398: 271139- ARROW DIAPHYSE D'ESSAI D8
• 03661489711381: 271138- ARROW DIAPHYSE D'ESSAI D6
• 03661489711374: 271137- ARROW COMPACTEUR T6
• 03661489711367: 271136- ARROW COMPACTEUR T5
• 03661489711350: 271135- ARROW COMPACTEUR T4
• 03661489711343: 271134- ARROW COMPACTEUR T3
• 03661489711336: 271133- ARROW COMPACTEUR T2
• 03661489711329: 271132- ARROW COMPACTEUR T1
• 03661489711312: 271131- ARROW COMPACTEUR INITIAL
• 03661489711305: 271130- ARROW GUIDE BROCHE
• 03661489711299: 271129- ARROW GABARIT T6 D16
• 03661489711282: 271128- ARROW GABARIT T5 D14
• 03661489711275: 271127- ARROW GABARIT T4 D12
• 03661489711268: 271126- ARROW GABARIT T3 D10
• 03661489711251: 271125- ARROW GABARIT T2 D8
• 03661489711244: 271124- ARROW GABARIT T1 D6
• 03661489711237: 271123- ARROW ADAPTATEUR POUR GUIDE DE COUPE
• 03661489711206: 271120- ARROW POINTE TROCART CANULEE
• 03661489711190: 271119- ARROW COUVERCLE UNIVERSEL
• 03661489711183: 271118- ARROW PANIER TIGE COURTE V1
• 03661489711107: 271110- ARROW METAPHYSE SANS CIMENT T6
• 03661489711091: 271109- ARROW METAPHYSE SANS CIMENT T5
• 03661489711084: 271108- ARROW METAPHYSE SANS CIMENT T4
• 03661489711077: 271107- ARROW METAPHYSE SANS CIMENT T3
• 03661489711060: 271106- ARROW METAPHYSE SANS CIMENT T2
• 03661489711053: 271105- ARROW METAPHYSE SANS CIMENT T1
• 03661489711046: 271104- ARROW TIGE DIAPHYSAIRE SANS CIMENT D16 L4
• 03661489711039: 271103- ARROW TIGE DIAPHYSAIRE SANS CIMENT D14 L4
• 03661489711022: 271102- ARROW TIGE DIAPHYSAIRE SANS CIMENT D12 L4
• 03661489711015: 271101- ARROW TIGE DIAPHYSAIRE SANS CIMENT D10 L4
• 03661489711008: 271100- ARROW TIGE DIAPHYSAIRE SANS CIMENT D8 L45
• 03661489710995: 271099- ARROW TIGE DIAPHYSAIRE SANS CIMENT D6 L45
• 03661489721144: 272114- ARROW SHORT STEM COVER
• 03661489721137: 272113- SHOULDER UNIVERSAL INSERT
• 03661489721120: 272112- SHOULDER UNIVERSAL TRAY
• 03661489720536: 272053- ARROW SHOULDER DISTRACTOR
• 03661489720512: 272051- ARROW TRIAL DIAPHYSIS HOLDER
• 03661489720505: 272050- ARROW ECCENTRIX SPACER FOR TRIAL METHAPHYS
• 03661489720499: 272049- ARROW STANDARD SPACER FOR TRIAL METHAPHYSI
• 03661489720482: 272048- ARROW SHORT REAMER D16