MAST QUADRANT™ Retractor System
GUDID 00643169195158
RETRACTOR EX0512303 MED/LAT RACK ASSM
MEDTRONIC SOFAMOR DANEK, INC.
Surgical retractor/retraction system blade, reusable| Primary Device ID | 00643169195158 |
| NIH Device Record Key | 66857a08-a5ad-4724-865c-421192ee91cf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MAST QUADRANT™ Retractor System |
| Version Model Number | EX0512303 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, 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 | false |
| 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 |
Customer Support Contacts
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169195158 [Primary] |
FDA Product Code
| GAD | RETRACTOR |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00643169195158]
Moist Heat or Steam Sterilization
[00643169195158]
Moist Heat or Steam Sterilization
[00643169195158]
Moist Heat or Steam Sterilization
[00643169195158]
Moist Heat or Steam Sterilization
[00643169195158]
Moist Heat or Steam Sterilization
[00643169195158]
Moist Heat or Steam Sterilization
[00643169195158]
Moist Heat or Steam Sterilization
[00643169195158]
Moist Heat or Steam Sterilization
[00643169195158]
Moist Heat or Steam Sterilization
[00643169195158]
Moist Heat or Steam Sterilization
[00643169195158]
Moist Heat or Steam Sterilization
[00643169195158]
Moist Heat or Steam Sterilization
[00643169195158]
Moist Heat or Steam Sterilization
[00643169195158]
Moist Heat or Steam Sterilization
[00643169195158]
Moist Heat or Steam Sterilization
[00643169195158]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-21 |
| Device Publish Date | 2022-10-13 |
On-Brand Devices [MAST QUADRANT™ Retractor System]
| 00613994537256 | BLADE X0308112 NARROW 12CM |
| 00613994537232 | BLADE X0308109 NARROW 9CM |
| 00613994107312 | INSTRUMENT X1105221 70MM LEFT HALF TUBE |
| 00613994107299 | INSTRUMENT X1105220 70MM RIGHT HALF TUBE |
| 00885074545530 | 80MM RIGHT HALF TUBE |
| 00885074545516 | 60MM RIGHT HALF TUBE |
| 00885074474496 | INSTRUMENT 9568008 MED LAT RACK ASSMBLY |
| 00885074055251 | INSTRUMENT 9568011 QUADRANT OPENER |
| 00885074055237 | CAPITAL 9569228 RIGHT HALF TUBE 80MM |
| 00885074055220 | CAPITAL 9569227 RIGHT HALF TUBE 70MM |
| 00885074055213 | CAPITAL 9569226 RIGHT HALF TUBE 60MM |
| 00885074055206 | CAPITAL 9569225 RIGHT HALF TUBE 50MM |
| 00885074055190 | CAPITAL 9569224 RIGHT HALF TUBE 40MM |
| 00885074055183 | CAPITAL 9568228 LEFT HALF TUBE 80MM |
| 00885074055176 | CAPITAL 9568227 LEFT HALF TUBE 70MM |
| 00885074055169 | CAPITAL 9568226 LEFT HALF TUBE 60MM |
| 00885074055152 | CAPITAL 9568225 LEFT HALF TUBE 50MM |
| 00885074055138 | CAPITAL 9568224 LEFT HALF TUBE 40MM |
| 00885074055121 | CAPITAL 9568010 ROT FLEX ARM ATTCHMNT |
| 00885074055046 | INSTRUMENT 9568000 QUADRANT RETRACTOR |
| 00885074042497 | INSTRUMENT 9560658 QUADRANT ILLUMIN SYS |
| 00885074474540 | INSTRUMENT 9568117 7CM NARROW BLADE |
| 00885074474533 | INSTRUMENT 9568115 5CM NARROW BLADE |
| 00885074474519 | INSTRUMENT 9568107 7CM WIDE BLADE |
| 00885074474502 | INSTRUMENT 9568105 5CM WIDE BLADE |
| 00885074474557 | INSTRUMENT 9568119 9CM NARROW BLADE |
| 00613994424563 | BLADE X1207106 16/40MM LEFT HALF TUBE |
| 00613994862396 | CAN OPENER EX0810500 DLIF |
| 00643169195165 | RETRACTOR EX0512304 RACK ASSEMBLY |
| 00643169195158 | RETRACTOR EX0512303 MED/LAT RACK ASSM |
| 00643169029217 | BLADE EX0511189 8CM STRAIGHT |
| 00643169029200 | BLADE EX0511188 6CM STRAIGHT |
| 00885074474526 | INSTRUMENT 9568109 9CM WIDE BLADE |
| 00643169169548 | 16MM HALF TUBE EX0412039 RIGHT 60MM |
| 00643169169531 | 16MM HALF TUBE EX0412038 RIGHT 40MM |
| 00643169169524 | 16MM HALF TUBE EX0412037 LEFT 60MM |
| 00643169169517 | 16MM HALF TUBE EX0412036 LEFT 40MM |
| 00613994876126 | RETRACTOR EX0910136 FRAME QUAD REVERSE |
Trademark Results [MAST QUADRANT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAST QUADRANT 78612711 3756155 Live/Registered |
Warsaw Orthopedic, Inc. 2005-04-20 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.