ACU-GUARD
GUDID 00814105020876
Acu-Guard II easy fit disposable clear sheaths sterile
ACUDERM, INC.
Medical equipment drape, single-use| Primary Device ID | 00814105020876 |
| NIH Device Record Key | c7cdfc4e-85dd-4c5d-af02-dc9330fde187 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACU-GUARD |
| Version Model Number | 0ADG51S |
| Company DUNS | 071426803 |
| Company Name | ACUDERM, INC. |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814105020876 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K915000
FDA Product Code
| GEX | Powered Laser Surgical Instrument |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2020-01-03 |
On-Brand Devices [ACU-GUARD]
| 10814105020873 | Acu-Guard II easy fit disposable clear sheaths sterile packaged 50/box |
| 10814105020866 | Acu-Guard II easy fit disposable clear sheaths non-sterile packaged 50/box |
| 10814105020859 | Acu-Guard II easy fit disposable clear sheaths non-sterile packaged 50/box |
| 00814105020876 | Acu-Guard II easy fit disposable clear sheaths sterile |
| 00814105020869 | Acu-Guard II easy fit disposable clear sheaths non-sterile |
| 00814105020852 | Acu-Guard II easy fit disposable clear sheaths non-sterile |
Trademark Results [ACU-GUARD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACU-GUARD 74420815 1831241 Live/Registered |
Acuderm Inc. 1993-08-05 |
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