50mm Single-Use Acetabular Reamer 11-100-0050

GUDID 00850032869027

Osteofit LLC

Bone-resection orthopaedic reamer, single-use

• Primary Device ID: 00850032869027
• NIH Device Record Key: 6f19e7f7-4a85-4a7c-9ede-1e2e96e350e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 50mm Single-Use Acetabular Reamer
• Version Model Number: 11-100-0050
• Catalog Number: 11-100-0050
• Company DUNS: 020886963
• Company Name: Osteofit LLC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00850032869027 [Primary]

FDA Product Code

• HWE: Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

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: 2022-08-12
• Device Publish Date: 2022-08-04

Devices Manufactured by Osteofit LLC

• 00850032869072 - 51mm Single-Use Acetabular Reamer: 2023-12-14
• 00850032869089 - 53mm Single-Use Acetabular Reamer: 2023-12-14
• 00850032869096 - 55mm Single-Use Acetabular Reamer: 2023-12-14
• 00850032869102 - 57mm Single-Use Acetabular Reamer: 2023-12-14
• 00850032869119 - 45mm Single-Use Acetabular Reamer: 2023-12-14
• 00850032869126 - 47mm Single-Use Acetabular Reamer: 2023-12-14
• 00850032869133 - 49mm Single-Use Acetabular Reamer: 2023-12-14
• 00850032869003 - 46mm Single-Use Acetabular Reamer: 2022-08-12