Primary Device ID | 00810633020463 |
NIH Device Record Key | b3f6d5d2-7cde-4944-9784-e3cf90bdbda5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Speed Shift |
Version Model Number | SE-2020-04 |
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 |
Phone | 210-881-0064 |
aknight@bme-tx.com | |
Phone | 210-881-0064 |
aknight@bme-tx.com | |
Phone | 210-881-0064 |
aknight@bme-tx.com | |
Phone | 210-881-0064 |
aknight@bme-tx.com | |
Phone | 210-881-0064 |
aknight@bme-tx.com | |
Phone | 210-881-0064 |
aknight@bme-tx.com | |
Phone | 210-881-0064 |
aknight@bme-tx.com | |
Phone | 210-881-0064 |
aknight@bme-tx.com | |
Phone | 210-881-0064 |
aknight@bme-tx.com | |
Phone | 210-881-0064 |
aknight@bme-tx.com | |
Phone | 210-881-0064 |
aknight@bme-tx.com | |
Phone | 210-881-0064 |
aknight@bme-tx.com | |
Phone | 210-881-0064 |
aknight@bme-tx.com | |
Phone | 210-881-0064 |
aknight@bme-tx.com | |
Phone | 210-881-0064 |
aknight@bme-tx.com | |
Phone | 210-881-0064 |
aknight@bme-tx.com | |
Phone | 210-881-0064 |
aknight@bme-tx.com | |
Phone | 210-881-0064 |
aknight@bme-tx.com |
Width | 20 Millimeter |
Width | 20 Millimeter |
Width | 20 Millimeter |
Width | 20 Millimeter |
Width | 20 Millimeter |
Width | 20 Millimeter |
Length | 4 Millimeter |
Length | 20 Millimeter |
Width | 20 Millimeter |
Length | 4 Millimeter |
Length | 20 Millimeter |
Width | 20 Millimeter |
Length | 4 Millimeter |
Length | 20 Millimeter |
Width | 20 Millimeter |
Length | 4 Millimeter |
Length | 20 Millimeter |
Width | 20 Millimeter |
Length | 4 Millimeter |
Length | 20 Millimeter |
Width | 20 Millimeter |
Length | 4 Millimeter |
Length | 20 Millimeter |
Width | 20 Millimeter |
Length | 4 Millimeter |
Length | 20 Millimeter |
Width | 20 Millimeter |
Length | 4 Millimeter |
Length | 20 Millimeter |
Width | 20 Millimeter |
Length | 4 Millimeter |
Length | 20 Millimeter |
Width | 20 Millimeter |
Length | 4 Millimeter |
Length | 20 Millimeter |
Width | 20 Millimeter |
Length | 4 Millimeter |
Length | 20 Millimeter |
Width | 20 Millimeter |
Length | 4 Millimeter |
Length | 20 Millimeter |
Width | 20 Millimeter |
Length | 4 Millimeter |
Length | 20 Millimeter |
Width | 20 Millimeter |
Length | 4 Millimeter |
Length | 20 Millimeter |
Width | 20 Millimeter |
Length | 4 Millimeter |
Length | 20 Millimeter |
Width | 20 Millimeter |
Length | 4 Millimeter |
Length | 20 Millimeter |
Width | 20 Millimeter |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00810633020463 [Primary] |
JDR | Staple, Fixation, Bone |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2020-05-07 |
Device Publish Date | 2015-10-24 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SPEED SHIFT 98641244 not registered Live/Pending |
Lubrication Specialties, LLC 2024-07-10 |
![]() 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 |