Aurora™ S130
GUDID 10810000527523
Aurora™ Barrier Sleeves (Pkg. of 1000 pcs.)
PARKELL, INC.
Medical equipment drape, single-use, non-sterile| Primary Device ID | 10810000527523 |
| NIH Device Record Key | 10e34edf-3c03-4f69-b19d-8daabf07d4f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aurora™ |
| Version Model Number | S130 |
| Catalog Number | S130 |
| Company DUNS | 009900424 |
| Company Name | PARKELL, INC. |
| Device Count | 1000 |
| DM Exempt | true |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810000527526 [Unit of Use] |
| GS1 | 10810000527523 [Primary] |
FDA Product Code
| EBZ | Activator, Ultraviolet, For Polymerization |
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 | 2019-09-30 |
| Device Publish Date | 2019-09-20 |
On-Brand Devices [Aurora™]
| 00810000520145 | Aurora™ S3 Replacement Battery D546 |
| 00810000520114 | Battery for Aurora™ Curing Light D540 |
| 00810000520091 | 110 Volt Battery Charger for Aurora™ D540 |
| M595D6750 | Aluminum Oxide (50micron) 5 Lbs. |
| M595D5490 | Aurora™ S3 Replacement Battery D546 |
| M595D5481 | Aurora™ S3 Tacking Lens D546 (Pkg. of 5 pcs.) |
| M595D5471 | Aurora™ S3 Curing Lens D546 (Pkg. of 10 pcs.) |
| M595D5440 | Battery for Aurora™ Curing Light D540 |
| M595D5431 | Tacking Lens for Aurora™ D540 (Pkg. of 5 pcs.) |
| M595D5421100 | 110 Volt Battery Charger for Aurora™ D540 |
| 10810000520135 | Aurora™ S3 Tacking Lens D546 (Pkg. of 5 pcs.) |
| 10810000520104 | Tacking Lens for Aurora™ D540 (Pkg. of 5 pcs.) |
| 10810000527523 | Aurora™ Barrier Sleeves (Pkg. of 1000 pcs.) |
| 10810000520128 | Aurora™ S3 Curing Lens D546 (Pkg. of 10 pcs.) |
| 10810000520081 | Curing Lens for Aurora™ D540 (Pkg. of 10 pcs.) |
Trademark Results [Aurora]
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