Adapter Sleeve 1034-0000J

GUDID 04546540169457

Morse/C-Taper

Howmedica Osteonics Corp.

Femoral head/stem prosthesis adaptor

• Primary Device ID: 04546540169457
• NIH Device Record Key: 652e4b21-5fdf-4fb1-984c-6261badaf37c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adapter Sleeve
• Version Model Number: 1034-0000J
• Catalog Number: 1034-0000J
• Company DUNS: 058311945
• Company Name: Howmedica Osteonics Corp.
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540169457 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K885102

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [Adapter Sleeve]

• 04546540608406: Universal V40 Taper Adapter Sleeve
• 04546540608390: Universal V40 Taper Adapter Sleeve
• 04546540608383: Universal V40 Taper Adapter Sleeve
• 04546540608345: Universal C-Taper Adapter Sleeve
• 04546540608338: Universal C-Taper Adapter Sleeve
• 04546540608321: Universal C-Taper Adapter Sleeve
• 04546540608314: Universal C-Taper Adapter Sleeve
• 04546540169457: Morse/C-Taper