BIOLOX DELTA 5010.42.322

GUDID 08033390007214

Biolox Delta Head 32mm #M

LIMACORPORATE SPA

Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis

• Primary Device ID: 08033390007214
• NIH Device Record Key: 642745c4-3c0e-455a-84f1-964446a49dfb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOLOX DELTA
• Version Model Number: Femoral Head
• Catalog Number: 5010.42.322
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390007214 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141327

FDA Product Code

• MBL: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-09
• Device Publish Date: 2015-07-31

On-Brand Devices [BIOLOX DELTA ]

• 08033390007269: Biolox Delta Head 36mm #XL
• 08033390007252: Biolox Delta Head 36mm #L
• 08033390007245: Biolox Delta Head 36mm #M
• 08033390007238: Biolox Delta Head 36mm #S
• 08033390007221: Biolox Delta Head 32mm #L
• 08033390007214: Biolox Delta Head 32mm #M
• 08033390007207: Biolox Delta Head 32mm #S
• 08033390007191: Biolox Delta Head 28mm #L
• 08033390007184: Biolox Delta Head 28mm #M
• 08033390007177: Biolox Delta Head 28mm #S
• 08033390184151: Biolox Delta - Femoral Head Dia. 40 mm #XL
• 08033390184144: Biolox Delta - Femoral Head Dia. 40 mm #L
• 08033390184137: Biolox Delta - Femoral Head Dia. 40 mm #M
• 08033390184120: Biolox Delta - Femoral Head Dia. 40 mm #S