DRILL BIT 61015
GUDID 00850003396279
Cannulated Drill Bit
Artelon
Cannulated surgical drill bit, single-use| Primary Device ID | 00850003396279 |
| NIH Device Record Key | 5eee5e7c-aa96-4adb-a87a-d270c93c197b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DRILL BIT |
| Version Model Number | 61015 |
| Catalog Number | 61015 |
| Company DUNS | 066284070 |
| Company Name | Artelon |
| 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 | true |
| Lot Batch | true |
| Serial Number | true |
| 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 Dimensions
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850003396279 [Primary] |
FDA Product Code
| HTW | Bit, Drill |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00850003396279]
Radiation Sterilization
[00850003396279]
Radiation Sterilization
[00850003396279]
Radiation Sterilization
[00850003396279]
Radiation Sterilization
[00850003396279]
Radiation Sterilization
[00850003396279]
Radiation Sterilization
[00850003396279]
Radiation Sterilization
[00850003396279]
Radiation Sterilization
[00850003396279]
Radiation Sterilization
[00850003396279]
Radiation Sterilization
[00850003396279]
Radiation Sterilization
[00850003396279]
Radiation Sterilization
[00850003396279]
Radiation Sterilization
[00850003396279]
Radiation Sterilization
[00850003396279]
Radiation Sterilization
[00850003396279]
Radiation Sterilization
[00850003396279]
Radiation Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-01 |
| Device Publish Date | 2023-05-24 |
Devices Manufactured by Artelon
| 00850003396248 - Twist Kit | 2024-04-19 Flexband 12cm device with anchors and instruments kit |
| 00850003396323 - Twist Kit | 2024-04-19 Flexband 30cm device with anchors and instruments kit |
| 00850003396347 - Twist Driver Kit | 2024-04-19 Twist 5.0mm Anchor on Driver. |
| 00850003396330 - Twist Driver Kit | 2024-04-18 Twist 3.85mm Anchor on Driver. |
| 00850003396187 - FlexBand Plus | 2023-06-01 FlexBand Plus 0.5 x 24 Strip with Suture |
| 00850003396200 - DRILL BIT AND GUIDE | 2023-06-01 Cannulated Drill Bit and Guide |
| 10850003396214 - FLEXBAND FIX | 2023-06-01 FLEXBAND and anchor kit with paddle handle |
| 00850003396255 - FlexBand Eyelet Anchor | 2023-06-01 Hex Eyelet Anchor |
Trademark Results [DRILL BIT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DRILL BIT 90253752 not registered Live/Pending |
DRILL BIT, LLC 2020-10-14 |
 DRILL BIT 76416543 2825984 Dead/Cancelled |
HASBRO, INC. 2002-05-31 |
 DRILL BIT 75188263 2159667 Dead/Cancelled |
HASBRO, INC. 1996-10-28 |
 DRILL BIT 73325061 1202692 Dead/Cancelled |
Hart Publications, Inc. 1981-08-24 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.