CeMend Shoulder Spacer Mold

GUDID 08058964728807

G21 SRL

Orthopaedic cement spacer mould

• Primary Device ID: 08058964728807
• NIH Device Record Key: b9cd7089-6a50-48d4-818c-902e0080a9dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CeMend Shoulder Spacer Mold
• Version Model Number: AR-902-1242M
• Company DUNS: 431529195
• Company Name: G21 SRL
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	08058964728807 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202338

FDA Product Code

• MBB: Bone Cement, Antibiotic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-09
• Device Publish Date: 2024-10-01

On-Brand Devices [CeMend Shoulder Spacer Mold]

• 08058964728777: AR-902-1042M
• 08058964728661: AR-902-0842M
• 08058964728869: AR-902-1048M
• 08058964728821: AR-902-1448M
• 08058964728814: AR-902-1248M
• 08058964728807: AR-902-1242M
• 08058964729149: AS-902-1448M
• 08058964729132: AS-902-1242M
• 08058964729125: AS-902-1048M
• 08058964729118: AS-902-1042M
• 08058964729095: AS-902-1248M
• 08058964729088: AS-902-0842M