STAPLIZER 7615-03
GUDID 20845854016425
16 X 15MM STAPLIZER BONE STAPLE CARTRIDGE, QTY 3
Conmed Corporation
Orthopaedic bone staple, non-adjustable| Primary Device ID | 20845854016425 |
| NIH Device Record Key | 23ba8a49-4ee8-4b9d-a681-8af08444dd77 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STAPLIZER |
| Version Model Number | 7615-03 |
| Catalog Number | 7615-03 |
| Company DUNS | 071595540 |
| Company Name | Conmed Corporation |
| Device Count | 3 |
| 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 | true |
| 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 Dimensions
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
| Width | 16 Millimeter |
| Height | 15 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00845854016421 [Unit of Use] |
| GS1 | 10845854016428 [Primary] |
| GS1 | 20845854016425 [Package] Contains: 10845854016428 Package: CARTON [3 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K840566
FDA Product Code
| JDR | STAPLE, FIXATION, BONE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-11-23 |
| Device Publish Date | 2015-10-24 |
On-Brand Devices [STAPLIZER]
| 10845854031933 | STAPLIZER DISASSEMBLY PUNCH REMOVAL TOOL |
| 10845854031766 | SEATER |
| 20845854016425 | 16 X 15MM STAPLIZER BONE STAPLE CARTRIDGE, QTY 3 |
| 20845854016296 | 7 X 10MM STAPLIZER BONE STAPLE CARTRIDGE, QTY 3 |
| 20845854016289 | 10 X 10MM STAPLIZER BONE STAPLE CARTRIDGE, QTY 3 |
| 20845854016067 | 13 X 15MM STAPLIZER BONE STAPLE CARTRIDGE, QTY 3 |
| 20845854016043 | 13 X 10MM STAPLIZER BONE STAPLE CARTRIDGE, QTY 3 |
| 20845854015923 | 10 X 7MM STAPLIZER BONE STAPLE CARTRIDGE, QTY 3 |
| 20845854015787 | 16 X 10MM STAPLIZER BONE STAPLE CARTRIDGE, QTY 3 |
| 20845854015770 | 16 X 20MM STAPLIZER BONE STAPLE CARTRIDGE, QTY 3 |
| 20845854015688 | 13 X 20MM STAPLIZER BONE STAPLE CARTRIDGE, QTY 3 |
| 20845854015671 | 10 X 15MM STAPLIZER BONE STAPLE CARTRIDGE, QTY 3 |
| 20845854015596 | 13 X 7MM STAPLIZER BONE STAPLE CARTRIDGE, QTY 3 |
| 20845854015589 | 16 X 25MM STAPLIZER BONE STAPLE CARTRIDGE, QTY 3 |
| 20845854015572 | 7 X 7MM STAPLIZER BONE STAPLE CARTRIDGE, QTY 3 |
| 10845854031735 | 13mm STAPLE CARRIER |
| 10845854031711 | 7mm STAPLE CARRIER |
| 10845854031759 | PRY |
| 10845854031742 | 16mm STAPLE CARRIER |
| 10845854031728 | 10mm STAPLE CARRIER |
Trademark Results [STAPLIZER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STAPLIZER 73626889 1439875 Live/Registered |
MINNESOTA MINING AND MANUFACTURING COMPANY 1986-10-27 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.