Speed Shift
GUDID 00810633020432
Speed Shift 15x20x20 Offset 8mm Implant
Biomedical Enterprises, Inc.
Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable| Primary Device ID | 00810633020432 |
| NIH Device Record Key | e3b5aeea-948f-48e8-bb7b-b09da68dc652 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Speed Shift |
| Version Model Number | SE-1520-08 |
| Company DUNS | 792619009 |
| Company Name | Biomedical Enterprises, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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
| Phone | 210-881-0043 |
| gupton@bme-tx.com | |
| Phone | 210-881-0043 |
| gupton@bme-tx.com | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
Device Dimensions
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810633020432 [Primary] |
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 | 3 |
| Public Version Date | 2020-05-07 |
| Device Publish Date | 2015-10-24 |
On-Brand Devices [Speed Shift]
| 00810633020517 | Shift Implant Sizer (Offset sizing tool) |
| 00810633020500 | Speed Shift 20x20x20 Offset 12mm Implant |
| 00810633020494 | Speed Shift 20x20x20 Offset 10mm Implant |
| 00810633020487 | Speed Shift 20x20x20 Offset 08mm Implant |
| 00810633020470 | Speed Shift 20x20x20 Offset 06mm Implant |
| 00810633020463 | Speed Shift 20x20x20 Offset 04mm Implant |
| 00810633020456 | Speed Shift 20x20x20 Offset 02mm Implant |
| 00810633020449 | Speed Shift 15x20x20 Offset 10mm Implant |
| 00810633020432 | Speed Shift 15x20x20 Offset 8mm Implant |
| 00810633020425 | Speed Shift 15x20x20 Offset 6mm Implant |
Trademark Results [Speed Shift]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPEED SHIFT 85427472 4160437 Live/Registered |
Reliable Diamond Tool, Inc. 2011-09-20 |
 SPEED SHIFT 76361484 2801780 Live/Registered |
Lifetime Products, Inc. 2002-01-22 |
 SPEED SHIFT 75425830 not registered Dead/Abandoned |
Lifetime Products, Inc. 1998-01-29 |
 SPEED SHIFT 75420200 2498603 Live/Registered |
INTIME SOLUTIONS INC. 1998-01-20 |
 SPEED SHIFT 74489800 not registered Dead/Abandoned |
Coastal Unilube, Inc. 1994-02-14 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.