ACCURIAN™
GUDID 00763000312251
INTRODUCER AI0005 100MM 12MM ENHANCED
MEDTRONIC SOFAMOR DANEK, INC.
Radio-frequency ablation system| Primary Device ID | 00763000312251 |
| NIH Device Record Key | 77268cf5-9c53-4ca6-90c2-d9b2ac374216 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACCURIAN™ |
| Version Model Number | AI0005 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| Device Count | 10 |
| DM Exempt | true |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
| Length | 100 Millimeter |
| Needle Gauge | 17 Gauge |
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000312251 [Unit of Use] |
| GS1 | 20763000312255 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K181864
FDA Product Code
| GEI | Electrosurgical, cutting & coagulation & accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-08 |
| Device Publish Date | 2020-05-31 |
On-Brand Devices [ACCURIAN™]
| 00763000312268 | INTRODUCER AI0006 150MM 12MM ENHANCED |
| 00763000312251 | INTRODUCER AI0005 100MM 12MM ENHANCED |
| 00763000312244 | INTRODUCER AI0004 50MM 12MM ENHANCED |
| 00763000312220 | INTRODUCER AI0002 100MM 10MM ENHANCED |
| 00763000312213 | INTRODUCER AI0001 50MM 10MM ENHANCED |
| 00763000312237 | INTRODUCER AI0003 150MM 10MM ENHANCED |
| 00763000405014 | SFTWR KIT AGSW001 ACCURIAN GENRTR 1.1 |
Trademark Results [ACCURIAN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCURIAN 87959954 5771242 Live/Registered |
Medtronic, Inc. 2018-06-13 |
 ACCURIAN 78931716 3469714 Dead/Cancelled |
TRS Quality, Inc. 2006-07-18 |
 ACCURIAN 78433632 3012289 Dead/Cancelled |
TRS Quality, Inc. 2004-06-11 |
 ACCURIAN 78433498 3181576 Dead/Cancelled |
TRS Quality, Inc. 2004-06-10 |
 ACCURIAN 78308158 2999052 Dead/Cancelled |
GENERAL WIRELESS IP HOLDINGS LLC 2003-10-01 |
ACCURIAN 78308158 2999052 Dead/Cancelled |
GENERAL WIRELESS OPERATIONS INC. 2003-10-01 |
 ACCURIAN 77298471 3426697 Dead/Cancelled |
TRS Quality, Inc. 2007-10-08 |
 ACCURIAN 77267478 not registered Dead/Abandoned |
TRS Quality, Inc. 2007-08-29 |
 ACCURIAN 77101675 not registered Dead/Abandoned |
TRS Quality, Inc. 2007-02-07 |
 ACCURIAN 77012615 3382456 Dead/Cancelled |
TRS Quality, Inc. 2006-10-03 |
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