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
| 00850017635180 - Austin Medical, Inc | 2025-12-30 Colic Decompression Simplex |
| 00850017635234 - Austin Medical, Inc | 2025-12-30 MPT Derm MM Clinic Pack |
| 00850017635272 - Austin Medical, Inc | 2025-12-30 Procedure Pack |
| 00850017635654 - Austin Medical, Inc | 2025-12-30 Hip Drape |
| 00850017635661 - Austin Medical, Inc | 2025-12-30 Eye Pack |
| 00850017635678 - Austin Medical, Inc | 2025-12-30 General Pack-Colic Resection Pack |
| 00850017635685 - Austin Medical, Inc | 2025-12-30 Minor Pack (Small Animal) |
| 00850017635692 - Austin Medical, Inc | 2025-12-30 Skin Prep |
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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