Clear Horizon AU-1008S
GUDID 10866001000329
"24"" x 24"" SMS Eye Drape w/ 1 fluid control pouch & 4"" x 5"" w/ Incise"
AUSTIN MEDICAL
Patient surgical drape, single-use, sterile| Primary Device ID | 10866001000329 |
| NIH Device Record Key | 8f1f3aff-fb53-46da-bc2d-5af1e41fcf0f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clear Horizon |
| Version Model Number | AU-1008S |
| Catalog Number | AU-1008S |
| Company DUNS | 010058700 |
| Company Name | AUSTIN MEDICAL |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00866001000322 [Primary] |
| GS1 | 10866001000329 [Package] Contains: 00866001000322 Package: Case [120 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K061422
FDA Product Code
| KKX | Drape, Surgical |
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 | 2018-11-08 |
| Device Publish Date | 2016-12-09 |
Devices Manufactured by AUSTIN MEDICAL
| 00850017635456 - Austin Medical, Inc. | 2022-01-18 Protego Pro Kit |
| 00866001000360 - Austin Medical, Inc. | 2021-12-17 Hemorrhage View C-section Drape |
| 00850017635425 - Austin | 2021-04-14 Mother’s Viewing Drape with Bleed ID Window |
| 00866001000315 - Austin Medical | 2018-11-08 Mother’s Viewing Drape - C-Section-sterile |
| 10866001000329 - Clear Horizon | 2018-11-08"24"" x 24"" SMS Eye Drape w/ 1 fluid control pouch & 4"" x 5"" w/ Incise" |
| 10866001000329 - Clear Horizon | 2018-11-08 "24"" x 24"" SMS Eye Drape w/ 1 fluid control pouch & 4"" x 5"" w/ Incise" |
| 00866001000346 - Austin | 2018-07-09 Total Capture Hysteroscopy Drape |
Trademark Results [Clear Horizon]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLEAR HORIZON 98460774 not registered Live/Pending |
Bright Horizons Legal LLC 2024-03-21 |
 CLEAR HORIZON 90210237 not registered Live/Pending |
Clear Distribution LLC 2020-09-25 |
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