Primary Device ID | 00840606167246 |
NIH Device Record Key | 5cf73953-f304-4de0-bac0-4ad45d6146dc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DIMENSION |
Version Model Number | 11178-015 |
Company DUNS | 610712213 |
Company Name | SPINAL ELEMENTS, INC. |
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 | false |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840606167246 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
[00840606167246]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-06-15 |
Device Publish Date | 2021-06-07 |
00840606167178 | Dimension® Split Tube Blade Set Tray Insert |
00840606167161 | Dimension® Split Tube Blade Set Tray Base |
00840606167154 | Dimension® Split Tube Blade Set Tray Lid |
00840606167147 | Dimension® Split Tube Blade Set Tray Assembly |
00840606167291 | DIMENSION® TLIF RETRACTOR DILATOR 1ST DILATOR |
00840606167260 | DIMENSION® TLIF RETRACTOR DILATOR 3RD DILATOR, 22MM |
00840606167253 | DIMENSION® TLIF RETRACTOR DILATOR 3RD DILATOR, 18MM |
00840606167246 | DIMENSION® TLIF RETRACTOR DILATOR 2ND DILATOR, 15MM |
00840606167239 | DIMENSION® TLIF RETRACTOR DILATOR 2ND DILATOR, 13MM |
00840606162227 | DIMENSION® 180° LEFT BLADE 18MM x 120MM |
00840606162210 | DIMENSION® 180° LEFT BLADE 18MM x 110MM |
00840606162203 | DIMENSION® 180° LEFT BLADE 18MM x 100MM |
00840606162197 | DIMENSION® 180° LEFT BLADE 18MM x 90MM |
00840606162180 | DIMENSION® 180° LEFT BLADE 18MM x 80MM |
00840606162173 | DIMENSION® 180° LEFT BLADE 18MM x 70MM |
00840606162166 | DIMENSION® 180° LEFT BLADE 18MM x 60MM |
00840606162159 | DIMENSION® 180° LEFT BLADE 18MM x 50MM |
00840606162142 | DIMENSION® 180° LEFT BLADE 18MM x 40MM |
00840606162135 | DIMENSION® 180° LEFT BLADE 22MM x 120MM |
00840606162128 | DIMENSION® 180° LEFT BLADE 22MM x 110MM |
00840606162111 | DIMENSION® 180° LEFT BLADE 22MM x 100MM |
00840606162104 | DIMENSION® 180° LEFT BLADE 22MM x 90MM |
00840606162098 | DIMENSION® 180° LEFT BLADE 22MM x 80MM |
00840606162081 | DIMENSION® 180° LEFT BLADE 22MM x 70MM |
00840606162074 | DIMENSION® 180° LEFT BLADE 22MM x 60MM |
00840606162067 | DIMENSION® 180° LEFT BLADE 22MM x 50MM |
00840606162050 | DIMENSION® 180° LEFT BLADE 22MM x 40MM |
00840606162043 | DIMENSION® 180° RIGHT BLADE 18MM x 120MM |
00840606162036 | DIMENSION® 180° RIGHT BLADE 18MM x 110MM |
00840606162029 | DIMENSION® 180° RIGHT BLADE 18MM x 100MM |
00840606162012 | DIMENSION® 180° RIGHT BLADE 18MM x 90MM |
00840606162005 | DIMENSION® 180° RIGHT BLADE 18MM x 80MM |
00840606161992 | DIMENSION® 180° RIGHT BLADE 18MM x 70MM |
00840606161985 | DIMENSION® 180° RIGHT BLADE 18MM x 60MM |
00840606161978 | DIMENSION® 180° RIGHT BLADE 18MM x 50MM |
00840606161961 | DIMENSION® 180° RIGHT BLADE 18MM x 40MM |
00840606161954 | DIMENSION® 180° RIGHT BLADE 22MM x 120MM |
00840606161947 | DIMENSION® 180° RIGHT BLADE 22MM x 110MM |
00840606161930 | DIMENSION® 180° RIGHT BLADE 22MM x 100MM |
00840606161923 | DIMENSION® 180° RIGHT BLADE 22MM x 90MM |
00840606161916 | DIMENSION® 180° RIGHT BLADE 22MM x 80MM |
00840606161909 | DIMENSION® 180° RIGHT BLADE 22MM x 70MM |
00840606161893 | DIMENSION® 180° RIGHT BLADE 22MM x 60MM |
00840606161886 | DIMENSION® 180° RIGHT BLADE 22MM x 50MM |
00840606161879 | DIMENSION® 180° RIGHT BLADE 22MM x 40MM |