| Primary Device ID | 00850032869102 |
| NIH Device Record Key | 904efe5b-fc9c-41e7-b618-df4851f17603 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 57mm Single-Use Acetabular Reamer |
| Version Model Number | 11-100-0057 |
| Catalog Number | 11-100-0057 |
| 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 |
| Phone | 862-210-8435 |
| jackie@osteofitllc.com | |
| Phone | 862-210-8435 |
| jackie@osteofitllc.com | |
| Phone | 862-210-8435 |
| jackie@osteofitllc.com | |
| Phone | 862-210-8435 |
| jackie@osteofitllc.com | |
| Phone | 862-210-8435 |
| jackie@osteofitllc.com | |
| Phone | 862-210-8435 |
| jackie@osteofitllc.com | |
| Phone | 862-210-8435 |
| jackie@osteofitllc.com | |
| Phone | 862-210-8435 |
| jackie@osteofitllc.com | |
| Phone | 862-210-8435 |
| jackie@osteofitllc.com | |
| Phone | 862-210-8435 |
| jackie@osteofitllc.com | |
| Phone | 862-210-8435 |
| jackie@osteofitllc.com | |
| Phone | 862-210-8435 |
| jackie@osteofitllc.com | |
| Phone | 862-210-8435 |
| jackie@osteofitllc.com | |
| Phone | 862-210-8435 |
| jackie@osteofitllc.com | |
| Phone | 862-210-8435 |
| jackie@osteofitllc.com | |
| Phone | 862-210-8435 |
| jackie@osteofitllc.com | |
| Phone | 862-210-8435 |
| jackie@osteofitllc.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850032869102 [Primary] |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-14 |
| Device Publish Date | 2023-12-06 |
| 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 |
| 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 |