NA
- Primary DI
- 10885862090232
- Brand
- NA
- Company
- Exactech, Inc.
- Model
- 400-30-21
- Catalog number
- 400-30-21
- Device description
- TAPERED REAMER
- Published
- 2022-07-28
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| HSZ | Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10885862090232 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 10885862090232 | 10885862090232 |
GMDN Terms
| Term | Definition |
|---|
| Bone-resection orthopaedic reamer, reusable | An orthopaedic surgical instrument designed to resect bone (cut out part of the bone) and precisely shape a specific area of bone as it is advanced for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). Commonly called a mill or a reamer it is typically designed as either a preshaped or a solid cylindrical body with an end/circumferential cutting edge, and is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy in varying sizes. This is a reusable device. |
Regulatory Flags
- DUNS number
- 157565946
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00887919964308 | Brasseler USA | Peter Brasseler Holdings, LLC | HSZ | 2024-11-19 |
| 00887919971733 | Brasseler USA | Peter Brasseler Holdings, LLC | HSZ | 2024-11-19 |
| 00887919971764 | Brasseler USA | Peter Brasseler Holdings, LLC | HSZ | 2024-11-19 |
| 00887919971795 | Brasseler USA | Peter Brasseler Holdings, LLC | HSZ | 2024-11-19 |
| 00763000714635 | MR8 | MEDTRONIC POWERED SURGICAL SOLUTIONS | HSZ | 2023-12-01 |
| 00763000865627 | MR8 | MEDTRONIC POWERED SURGICAL SOLUTIONS | HSZ | 2023-12-01 |
| 08800017288376 | LOSPA IS Spinal System | Corentec Co., Ltd | HSZ | 2022-10-21 |
| 10885862090454 | Acudriver | Exactech, Inc. | HSZ | 2022-09-19 |
| 10885862090560 | NA | Exactech, Inc. | HSZ | 2022-09-19 |
| 00847399004338 | MicroAire® | Microaire Surgical Instruments LLC | HSZ | 2022-09-17 |
| 00847399004765 | MicroAire® | Microaire Surgical Instruments LLC | HSZ | 2022-09-01 |
| 10885862090225 | NA | Exactech, Inc. | HSZ | 2022-07-28 |
| 10885862090256 | NA | Exactech, Inc. | HSZ | 2022-07-28 |
| 10885862090263 | NA | Exactech, Inc. | HSZ | 2022-07-28 |
| 10885862090362 | NA | Exactech, Inc. | HSZ | 2022-07-28 |
| 10885862090379 | NA | Exactech, Inc. | HSZ | 2022-07-28 |
| 10885862090416 | NA | Exactech, Inc. | HSZ | 2022-07-28 |
| 10885862090423 | NA | Exactech, Inc. | HSZ | 2022-07-28 |
| 10885862090430 | NA | Exactech, Inc. | HSZ | 2022-07-28 |
| 10885862090485 | NA | Exactech, Inc. | HSZ | 2022-07-28 |
| 10885862090492 | NA | Exactech, Inc. | HSZ | 2022-07-28 |
| 10885862090508 | NA | Exactech, Inc. | HSZ | 2022-07-28 |
| 10885862090522 | NA | Exactech, Inc. | HSZ | 2022-07-28 |
| 10885862090539 | NA | Exactech, Inc. | HSZ | 2022-07-28 |
| 10885862090546 | NA | Exactech, Inc. | HSZ | 2022-07-28 |
| 00763000513443 | MIDAS REX MR8 | MEDTRONIC POWERED SURGICAL SOLUTIONS | HSZ | 2022-06-30 |
| 00763000513450 | MIDAS REX MR8 | MEDTRONIC POWERED SURGICAL SOLUTIONS | HSZ | 2022-06-30 |
| 00763000513832 | MIDAS REX MR8 | MEDTRONIC POWERED SURGICAL SOLUTIONS | HSZ | 2022-04-22 |
| 00763000513863 | MIDAS REX MR8 | MEDTRONIC POWERED SURGICAL SOLUTIONS | HSZ | 2022-04-22 |
| 00763000513870 | MIDAS REX MR8 | MEDTRONIC POWERED SURGICAL SOLUTIONS | HSZ | 2022-04-22 |