Anspach Helix™ M-2B-HX-G1
GUDID 00845384017974
ANSPACH HELIX™ 2 mm Fluted Ball, Extended Length
Anspach Effort, The
Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use| Primary Device ID | 00845384017974 |
| NIH Device Record Key | ff528feb-bad9-4c4e-9947-0e16873edb0d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Anspach Helix™ |
| Version Model Number | M-2B-HX-G1 |
| Catalog Number | M-2B-HX-G1 |
| Company DUNS | 079116867 |
| Company Name | Anspach Effort, The |
| 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 | true |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00845384017974 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K183545
FDA Product Code
| HBE | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) |
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 | 2019-12-19 |
| Device Publish Date | 2019-12-11 |
On-Brand Devices [Anspach Helix™]
| 00845384018247 | ANSPACH HELIX™ 7 mm Fluted Ball |
| 00845384018230 | ANSPACH HELIX™ 6 mm Fluted Ball |
| 00845384018223 | ANSPACH HELIX™ 5 mm Fluted Ball |
| 00845384018216 | ANSPACH HELIX™ 4 mm Fluted Ball |
| 00845384018186 | ANSPACH HELIX™ 3 mm Fluted Ball, Extended Length |
| 00845384018179 | ANSPACH HELIX™ 3 mm Fluted Ball, Standard Length |
| 00845384018148 | ANSPACH HELIX™ 2 mm Fluted Ball, Extended Length |
| 00845384018131 | ANSPACH HELIX™ 2 mm Fluted Ball, Standard Length |
| 00845384018070 | ANSPACH HELIX™ 7 mm Fluted Ball |
| 00845384018063 | ANSPACH HELIX™ 6 mm Fluted Ball |
| 00845384018056 | ANSPACH HELIX™ 5 mm Fluted Ball |
| 00845384018049 | ANSPACH HELIX™ 4 mm Fluted Ball |
| 00845384018018 | ANSPACH HELIX™ 3 mm Fluted Ball, Extended Length |
| 00845384018001 | ANSPACH HELIX™ 3 mm Fluted Ball, Standard Length |
| 00845384017974 | ANSPACH HELIX™ 2 mm Fluted Ball, Extended Length |
| 00845384017967 | ANSPACH HELIX™ 2 mm Fluted Ball, Standard Length |
| 00845384017905 | ANSPACH HELIX™ 7 mm Fluted Ball |
| 00845384017899 | ANSPACH HELIX™ 6 mm Fluted Ball |
| 00845384017882 | ANSPACH HELIX™ 5 mm Fluted Ball |
| 00845384017875 | ANSPACH HELIX™ 4 mm Fluted Ball |
| 00845384017868 | ANSPACH HELIX™ 3.5 mm Fluted Ball, Extended Length |
| 00845384017851 | ANSPACH HELIX™ 3.5 mm Fluted Ball, Standard Length |
| 00845384017844 | ANSPACH HELIX™ 3 mm Fluted Ball, Extended Length |
| 00845384017837 | ANSPACH HELIX™ 3 mm Fluted Ball, Standard Length |
| 00845384017820 | ANSPACH HELIX™ 2.5 mm Fluted Ball, Extended Length |
Trademark Results [Anspach Helix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ANSPACH HELIX 88144797 not registered Live/Pending |
DePuy Synthes, Inc. 2018-10-05 |
 ANSPACH HELIX 86566073 not registered Dead/Abandoned |
DePuy Synthes, Inc. 2015-03-17 |
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