HemiCAP® 8000-4010
GUDID M528800040100
DISPOSABLE REAMER, 40MM
ARTHROSURFACE INCORPORATED
Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use| Primary Device ID | M528800040100 |
| NIH Device Record Key | b42747e8-470a-4ca6-8f24-849018b23e3e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HemiCAP® |
| Version Model Number | 8000-4010 |
| Catalog Number | 8000-4010 |
| Company DUNS | 144666109 |
| Company Name | ARTHROSURFACE INCORPORATED |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M528800040100 [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 | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-07-23 |
| Device Publish Date | 2018-04-17 |
On-Brand Devices [HemiCAP®]
| M528800040100 | DISPOSABLE REAMER, 40MM |
| M52891522545W0 | 15mm Articular Comp 2.5mm x 4.5mm MTP CE |
| M52891522545A0 | 15mm Articular Comp 2.5mm x 4.5mm MTP |
| M52891522535W0 | 15mm Articular Comp 2.5mm x 3.5mm MTP CE |
| M52891522535A0 | 15mm Articular Comp 2.5mm x 3.5mm MTP |
| M52891522040W0 | 15mm Articular Comp 2.0mm x 4.0mm MTP CE |
| M52891522040A0 | 15mm Articular Comp 2.0mm x 4.0mm MTP |
| M52891522030W0 | 15mm Articular Comp 2.0mm x 3.0mm MTP CE |
| M52891522030A0 | 15mm Articular Comp 2.0mm x 3.0mm MTP |
| M52891521535W0 | 15mm Articular Comp 1.5mm x 3.5mm MTP CE |
| M52891521535A0 | 15mm Articular Comp 1.5mm x 3.5mm MTP |
| M52891521525W0 | 15mm Articular Comp 1.5mm x 2.5mm MTP CE |
| M52891521525A0 | 15mm Articular Comp 1.5mm x 2.5mm MTP |
| M52891222030W0 | 12mm Art Comp 2.0mm x 3.0mm, MTP CE |
| M52891222030A0 | 12mm Art Comp 2.0mm x 3.0mm, MTP |
| M52891222025W0 | 12mm Art Comp 2.0mm x 2.5mm, MTP CE |
| M52891222025A0 | 12mm Art Comp 2.0mm x 2.5mm, MTP |
| M52891221525W0 | 12mm Art Comp 1.5mm x 2.5mm, MTP CE |
| M52891221525A0 | 12mm Art Comp 1.5mm x 2.5mm, MTP |
| M52891221520W0 | 12mm Art Comp 1.5mm x 2.0mm, MTP CE |
| M52891221520A0 | 12mm Art Comp 1.5mm x 2.0mm, MTP |
| M52891221020W0 | 12mm Art Comp 1.0mm x 2.0mm, MTP CE |
| M52891221020A0 | 12mm Art Comp 1.0mm x 2.0mm, MTP |
| M52891221015W0 | 12mm Art Comp 1.0mm x 1.5mm, MTP CE |
| M52891221015A0 | 12mm Art Comp 1.0mm x 1.5mm, MTP |
| M52890950018W0 | 9.5mm x 18mm, Taper Post, MTP CE |
| M52890950018A0 | 9.5mm x 18mm, Taper Post, MTP |
| M52890800016W0 | 8.0mm x 16mm, Taper Post, MTP CE |
| M52890800016A0 | 8.0mm x 16mm, Taper Post, MTP |
| M52890700013W0 | Taper Post, 7.0mm Dia X 13mm Lg, MTP CE |
Trademark Results [HemiCAP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMICAP 78225563 3039890 Live/Registered |
ARTHROSURFACE INCORPORATED 2003-03-14 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.