Invenio
EENT Pack 1_Sterile_5ea/cs
2manufacturers in China registered for this device type
14catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (1), Anhui (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Record
| Listed by | GRI Medical & Electronic Technology Co., Ltd., China |
|---|---|
| FDA product code | OGR |
| Device type | Ear, Nose, And Throat Surgical Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-02-17 |
| Record revised | 2024-09-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 6, pack of 4, pack of 2, pack of 5, pack of 3 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| i86-04201-S | In distribution | |
| STM004 | In distribution | |
| APS006 | In distribution | |
| i89-04204-S | In distribution | |
| IPS022 | In distribution | |
| NAR011 | In distribution | |
| NAR008 | In distribution | |
| i86-04204-S | In distribution | |
| ILS007 | In distribution | |
| NAR005 | In distribution | |
| OKL021 | In distribution | |
| TUF015 | In distribution | |
| i89-04201-S | In distribution | |
| CSC003 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 16,169 |
| Medline Industries, Inc. | Medline Industries, Inc. | 8,277 |
| ACS | American Contract Systems, Inc. | 472 |
| Centurion | Centurion Medical Products Corporation | 124 |
| Regard™ | ROi CPS LLC | 76 |
| Aligned Medical Solutions | Aligned Medical Solutions | 75 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 33 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 22 |
| Stradis Healthcare | Stradis Healthcare | 15 |
| Integra® MicroFrance® | Integra LifeSciences Production Corporation | 14 |
| DeRoyal | Deroyal Industries, Inc. | 11 |
| Invenio | GRI-Alleset, Inc. | 8 |
Showing 12 of 23. All products under Ear, Nose, And Throat Surgical Tray
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.