HYPERFLEX 8572
GUDID 00845854025331
1.6 X 356MM (.062IN X 14IN) HYPERFLEX FLEXIBLE GUIDE WIRE
Conmed Corporation
Electrical-only medical device connection cable, reusable| Primary Device ID | 00845854025331 |
| NIH Device Record Key | cd9b1e2a-51cf-4fa3-9b95-e5c16bd8c3bb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HYPERFLEX |
| Version Model Number | 8572 |
| Catalog Number | 8572 |
| Company DUNS | 071595540 |
| Company Name | Conmed Corporation |
| Device Count | 5 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00845854025331 [Unit of Use] |
| GS1 | 10845854025338 [Primary] |
| GS1 | 20845854025335 [Direct Marking] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K941711
FDA Product Code
| HXB | PROBE |
| LXH | Orthopedic manual surgical instrument |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-19 |
| Device Publish Date | 2021-10-11 |
On-Brand Devices [HYPERFLEX]
| 20845854041618 | HYPERFLEX GUIDEWIRE, NITINOL, 9 IN, STERILE, 1.6 X 229MM (.062 X 9IN) |
| 20845854041632 | HYPERFLEX GUIDEWIRE, NITINOL, 18.5IN, STERILE |
| 20845854041625 | HYPERFLEX GUIDEWIRE, NITINOL, 14IN, STERILE |
| 00845854025331 | 1.6 X 356MM (.062IN X 14IN) HYPERFLEX FLEXIBLE GUIDE WIRE |
| 00845854025317 | 1.6 X 229MM (.062 IN X 9IN) HYPERFLEX NITINOL GUIDE WIRE |
Trademark Results [HYPERFLEX]
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.