Xcel 3910-300-015
GUDID 37613154092605
3MM XCEL WITH 1 STRAND #2 FORCE FIBER
STRYKER CORPORATION
Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable| Primary Device ID | 37613154092605 |
| NIH Device Record Key | 2a9a3705-aad5-412b-b1d2-7d568ed8b57c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Xcel |
| Version Model Number | 3910-300-015 |
| Catalog Number | 3910-300-015 |
| Company DUNS | 187502109 |
| Company Name | STRYKER CORPORATION |
| 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
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613154092604 [Primary] |
| GS1 | 37613154092605 [Package] Contains: 07613154092604 Package: pack [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K041307
FDA Product Code
| MAI | FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-03-21 |
| Device Publish Date | 2015-09-08 |
On-Brand Devices [Xcel]
| 37613154567240 | XCEL RC |
| 07613154567232 | 3.5MM X 24MM XCEL ANCHOR RC AWL |
| 07613154567225 | XCEL ANCHOR RC GUIDE |
| 07613154567218 | XCEL ANCHOR RC OBTURATOR |
| 07613154567201 | 3.5MM X 24MM XCEL ANCHOR RC DRILL |
| 37613154092605 | 3MM XCEL WITH 1 STRAND #2 FORCE FIBER |
| 07613154083299 | 3MM X 24MM XCEL DRILL |
| 34546540392481 | 3MM XCEL WITH 1 STRAND #2 BRAIDED POLYESTER |
Trademark Results [Xcel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 XCEL 98329751 not registered Live/Pending |
360 Pet Care LLC 2023-12-25 |
 XCEL 98079306 not registered Live/Pending |
360 Pet Care LLC 2023-07-11 |
 XCEL 97631216 not registered Live/Pending |
Xcel Products Inc. 2022-10-13 |
 XCEL 97631149 not registered Live/Pending |
Xcel Products Inc. 2022-10-13 |
 XCEL 97534624 not registered Live/Pending |
Extract Production Services, LLC 2022-08-04 |
 XCEL 97481297 not registered Live/Pending |
Biomeme, Inc. 2022-06-29 |
 XCEL 97270215 not registered Live/Pending |
360 Pet Care LLC 2022-02-16 |
 XCEL 97235949 not registered Live/Pending |
No Xcuses Just Results, LLC 2022-01-24 |
 XCEL 97225571 not registered Live/Pending |
Rochelle Community Hospital Association 2022-01-18 |
 XCEL 90883193 not registered Live/Pending |
Prymexcel LLC 2021-08-14 |
 XCEL 90372969 not registered Live/Pending |
Klearstand, Inc. 2020-12-10 |
 XCEL 88462225 not registered Live/Pending |
PRIME Strategy Inc. 2019-06-06 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.