Primary Device ID | 00849044092165 |
NIH Device Record Key | db24d42b-c961-401e-bb02-af4c6692c4f6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SP-FIX |
Version Model Number | 388.322 |
Company DUNS | 139105691 |
Company Name | GLOBUS MEDICAL, INC. |
Device Count | 1 |
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 | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | +1(610)930-1800 |
info@globusmedical.com |
Length | 22 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00849044092165 [Primary] |
KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00849044092165]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-04-25 |
Device Publish Date | 2015-11-07 |
00849044092639 | Plate Trial, 26mm |
00849044092622 | LP-Ti Barrel Trial, 22mm |
00849044092547 | Trial, 22mm |
00849044092448 | SP-Fix Set Screw Locking Plate, 55mm |
00849044092431 | SP-Fix Set Screw Locking Plate, 50mm |
00849044092424 | SP-Fix Set Screw Locking Plate, 47mm |
00849044092417 | SP-Fix Set Screw Locking Plate, 44mm |
00849044092400 | SP-Fix Set Screw Locking Plate, 41mm |
00849044092394 | SP-Fix Set Screw Locking Plate, 38mm |
00849044092387 | SP-Fix Set Screw Locking Plate, 35mm |
00849044092370 | SP-Fix Set Screw Locking Plate, 32mm |
00849044092363 | SP-Fix Set Screw Locking Plate, 29mm |
00849044092356 | SP-Fix Set Screw Locking Plate, 26mm |
00849044092349 | SP-Fix Double Tab Locking Plate, 55mm |
00849044092332 | SP-Fix Double Tab Locking Plate, 50mm |
00849044092325 | SP-Fix Double Tab Locking Plate, 47mm |
00849044092318 | SP-Fix Double Tab Locking Plate, 44mm |
00849044092301 | SP-Fix Double Tab Locking Plate, 41mm |
00849044092295 | SP-Fix Double Tab Locking Plate, 38mm |
00849044092288 | SP-Fix Double Tab Locking Plate, 35mm |
00849044092271 | SP-Fix Double Tab Locking Plate, 32mm |
00849044092264 | SP-Fix Double Tab Locking Plate, 29mm |
00849044092257 | SP-Fix Double tab Locking Plate, 26mm |
00849044092240 | SP-Fix LP PEEK Barrel Assembly, 22mm |
00849044092233 | SP-Fix LP PEEK Barrel Assembly, 20mm |
00849044092226 | SP-Fix LP PEEK Barrel Assembly, 18mm |
00849044092219 | SP-Fix LP PEEK Barrel Assembly, 16mm |
00849044092202 | SP-Fix LP PEEK Barrel Assembly, 14mm |
00849044092196 | SP-Fix LP PEEK Barrel Assembly, 12mm |
00849044092189 | SP-Fix LP PEEK Barrel Assembly, 10mm |
00849044092172 | Sp-Fix LP PEEK Barrel Assembly, 8mm |
00849044092165 | SP-Fix Standard PEEK Barrel Assembly, 22mm |
00849044092158 | SP-Fix Standard PEEK Barrel Assembly, 20mm |
00849044092141 | SP-Fix Standard PEEK Barrel Assembly, 18mm |
00849044092134 | SP-Fix Standard PEEK Barrel Assembly, 16mm |
00849044092127 | SP-Fix Standard PEEK Barrel Assembly, 14mm |
00849044092110 | SP-Fix Standard PEEK Barrel Assembly, 12mm |
00849044092103 | SP-Fix Standard PEEK Barrel Assembly, 10mm |
00849044092097 | SP-Fix Standard PEEK Barrel Assembly, 8mm |
00849044092080 | SP-Fix Ti Barrel Assembly, 22mm |
00849044092073 | SP-Fix Ti Barrel Assembly, 20mm |
00849044092066 | SP-Fix Ti Barrel Assembly, 18mm |
00849044092059 | SP-Fix Ti Barrel Assembly, 16mm |
00849044092042 | SP-Fix Ti Barrel Assembly, 14mm |
00849044092035 | SP-Fix Ti Barrel Assembly, 12mm |
00849044092028 | SP-Fix Ti Barrel Assembly, 10mm |
00849044092011 | SP-Fix Ti Barrel Assembly, 8mm |
00849044092004 | SP-Fix Ratcheting Rod, 35mm |
00849044091991 | SP-Fix Ratcheting Rod, 30mm |
00849044091984 | SP-Fix Ratcheting Rod, 25mm |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SP-FIX 85051909 4094316 Live/Registered |
Globus Medical, Inc. 2010-06-01 |