Elbow B11264

GUDID 05055348260819

HUGH STEEPER LIMITED

Body-powered elbow prosthesis, locking

• Primary Device ID: 05055348260819
• NIH Device Record Key: 61fea37e-87ab-4826-9a40-8dcf92f652fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elbow
• Version Model Number: Right Lateral Free Swing
• Catalog Number: B11264
• Company DUNS: 210280350
• Company Name: HUGH STEEPER LIMITED
• 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: 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	05055348260819 [Primary]

FDA Product Code

• IRD: Joint, Elbow, External Limb Component, Mechanical

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: 2023-07-28
• Device Publish Date: 2023-07-20

On-Brand Devices [Elbow]

• 05055348262233: Left Medial – Manual Lock Flail Arm Application
• 05055348262226: Right Medial – Manual Lock Flail Arm Application
• 05055348260819: Right Lateral Free Swing
• 05055348260802: Left Lateral Free Swing
• 05055348259912: Plain Joint Right Medial/Left Lateral- Free Swing
• 05055348259547: Right Medial Friction Steel
• 05055348259530: Left Medial Friction Steel
• 05055348226860: Left/Right Lateral Free Swing
• 05055348201348: Right Medial -Auto Lock
• 05055348201331: Left Medial – Auto Lock
• 05055348247827: Automatic Elbow, Child, Flesh Pink
• 05055348247810: Automatic Elbow, Adult, Suntan
• 05055348247803: Automatic Elbow, Adult, Flesh Pink
• 05055348201287: Lateral Ring 5inch Taper 70mm
• 05055348201263: Lateral Ring Parallel 64mm
• 05055348201256: Lateral Ring Parallel 58mm
• 05055348259974: Plain Joint Left Medial/Right Lateral- Free Swing
• 05055348201317: Adult Manual Elbow 70mm, Dark Brown
• 05055348201294: Adult Manual Elbow 70mm, Flesh Pink
• 05055348201188: Adult Forearm, 70mm, 50mm Wrist, Suntan
• 05055348201171: Adult Forearm, 70mm, 50mm Wrist, Flesh Pink
• 05055348201102: Childs Forearm 58mm, 45mm Wrist, Suntan
• 05055348201096: Childs Forearm 58mm, 45mm Wrist, Flesh Pink
• 05055348201065: Adolescent Forearm, 64mm, 50mm Wrist, Suntan
• 05055348201058: Adolescent Forearm, 64mm, 50mm Wrist, Flesh Pink
• 05055348262134: Child Friction Elbow 38mm
• 05055348262127: Child Friction Elbow 45mm
• 05055348247797: Automatic Elbow, Adolescent, Suntan
• 05055348247780: Automatic Elbow, Adolescent, Flesh Pink
• 05055348201218: Adult Forearm, 70mm, 54mm Wrist, Flesh Pink