BIOLOX DELTA 5010.42.364

GUDID 08033390007269

Biolox Delta Head 36mm #XL

LIMACORPORATE SPA

Ceramic femoral head prosthesis

• Primary Device ID: 08033390007269
• NIH Device Record Key: c8b6027d-e477-40c1-aa12-9185d21c6a09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOLOX DELTA
• Version Model Number: Femoral Head
• Catalog Number: 5010.42.364
• 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	08033390007269 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141327

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

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