ESPIRE EEH-LBLS

GUDID 05056394327167

HUGH STEEPER LIMITED

Electrical elbow prosthesis

• Primary Device ID: 05056394327167
• NIH Device Record Key: f470bf3f-2608-4ae5-9ea6-3f9516b1e1d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESPIRE
• Version Model Number: Espire Elbow Hybrid- Left- Brown- Lateral Dial- Sm
• Catalog Number: EEH-LBLS
• Company DUNS: 210280350
• Company Name: HUGH STEEPER LIMITED
• 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: false
• 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	05056394327167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182757

FDA Product Code

• IRE: Joint, Elbow, External Limb Component, Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-06
• Device Publish Date: 2023-06-28

On-Brand Devices [ESPIRE]

• 05056394326061: Espire Battery Charger- Dual Bay- US
• 05056394326030: Espire Battery Charger- Single Bay- US
• 05056394326009: Espire Battery Car Charger-US
• 05056394325972: Espire Bump Switch
• 05056394325484: Espire Battery
• 05056394327228: Espire Elbow Hybrid- Left- Caucasian- Lateral Dial
• 05056394327211: Espire Elbow Hybrid- Left- Brown- Medial Dial- Sma
• 05056394327204: Espire Elbow Hybrid- Left- Brown- Medial Dial- Sma
• 05056394327198: Espire Elbow Hybrid- Left- Brown- Medial Dial- Sta
• 05056394327181: Espire Elbow Hybrid- Left- Brown- Medial Dial- Sta
• 05056394327174: Espire Elbow Hybrid- Left- Brown- Lateral Dial- Sm
• 05056394327167: Espire Elbow Hybrid- Left- Brown- Lateral Dial- Sm
• 05056394327150: Espire Elbow Hybrid- Left- Brown- Lateral Dial- St
• 05056394327143: Espire Elbow Hybrid- Left- Brown- Lateral Dial- St
• 05056394327136: Espire Elbow Hybrid- Left- Black Carbon Finish- Me
• 05056394327129: Espire Elbow Hybrid- Left- Black Carbon Finish- Me
• 05056394327112: Espire Elbow Hybrid- Left- Black Carbon Finish- Me
• 05056394327105: Espire Elbow Hybrid- Left- Black Carbon Finish- Me
• 05056394327099: Espire Elbow Hybrid- Left- Black Carbon Finish- La
• 05056394327082: Espire Elbow Hybrid- Left- Black Carbon Finish- La
• 05056394327075: Espire Elbow Hybrid- Left- Black Carbon Finish- La
• 05056394327068: Espire Elbow Hybrid- Left- Black Carbon Finish- La
• 05056394327051: Forearm Cable Lift Kit- Standard
• 05056394327044: Forearm Cable Lift Kit- Extended
• 05056394326313: Espire DC Cased Electrode Cable
• 05056394328065: Espire Elbow Pro- Left- Black Carbon Finish- Stand
• 05056394328058: Espire Elbow Pro- Left- Black Carbon Finish- Stand
• 05056394327822: Espire Elbow Hybrid- Right- Jet Black- Medial Dial
• 05056394327761: Espire Elbow Hybrid- Right- Caucasian- Medial Dial
• 05056394327754: Espire Elbow Hybrid- Right- Caucasian- Medial Dial
• 05056394327709: Espire Elbow Hybrid- Right- Caucasian- Lateral Dia
• 05056394327587: Espire Elbow Hybrid- Right- Black Carbon Finish- M
• 05056394327556: Espire Elbow Hybrid- Right- Black Carbon Finish- L
• 05056394327372: Espire Elbow Hybrid- Left- Jet Black- Medial Dial-
• 05056394327341: Espire Elbow Hybrid- Left- Jet Black- Medial Dial-
• 05056394327280: Espire Elbow Hybrid- Left- Caucasian- Medial Dial-
• 05056394327266: Espire Elbow Hybrid- Left- Caucasian- Medial Dial-
• 05056394328485: Espire Elbow Pro- Right- Silver- Small- COAPT
• 05056394328447: Espire Elbow Pro- Right- Jet Black- Small- COAPT
• 05056394328430: Espire Elbow Pro- Right- Jet Black- Small
• 05056394328423: Espire Elbow Pro- Right- Jet Black- Standard- COAP
• 05056394328416: Espire Elbow Pro- Right- Jet Black- Standard
• 05056394328393: Espire Elbow Pro- Right- Caucasian- Small
• 05056394328379: Espire Elbow Pro- Right- Caucasian- Standard
• 05056394328331: Espire Elbow Pro- Right- Brown- Standard
• 05056394328324: Espire Elbow Pro- Right- Black Carbon Finish- Smal
• 05056394328317: Espire Elbow Pro- Right- Black Carbon Finish- Smal
• 05056394328300: Espire Elbow Pro- Right- Black Carbon Finish- Stan
• 05056394328294: Espire Elbow Pro- Right- Black Carbon Finish- Stan
• 05056394328263: Espire Elbow Pro- Left- White- Standard- COAPT