| Primary Device ID | 08175700101097 |
| NIH Device Record Key | 61ca4908-849e-42dd-9fc1-8b361cc548e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ophthalmic Speculum |
| Version Model Number | AS1-100CKS |
| Catalog Number | AS1-100CKS |
| Company DUNS | 968368832 |
| Company Name | AURORA SURGICAL, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08175700101097 [Primary] |
| HNC | Specula, Ophthalmic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08175700101097]
Moist Heat or Steam Sterilization
[08175700101097]
Moist Heat or Steam Sterilization
[08175700101097]
Moist Heat or Steam Sterilization
[08175700101097]
Moist Heat or Steam Sterilization
[08175700101097]
Moist Heat or Steam Sterilization
[08175700101097]
Moist Heat or Steam Sterilization
[08175700101097]
Moist Heat or Steam Sterilization
[08175700101097]
Moist Heat or Steam Sterilization
[08175700101097]
Moist Heat or Steam Sterilization
[08175700101097]
Moist Heat or Steam Sterilization
[08175700101097]
Moist Heat or Steam Sterilization
[08175700101097]
Moist Heat or Steam Sterilization
[08175700101097]
Moist Heat or Steam Sterilization
[08175700101097]
Moist Heat or Steam Sterilization
[08175700101097]
Moist Heat or Steam Sterilization
[08175700101097]
Moist Heat or Steam Sterilization
[08175700101097]
Moist Heat or Steam Sterilization
[08175700101097]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-21 |
| Device Publish Date | 2023-12-13 |
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