Integra® MicroFrance®
LOANER Functional Endoscopic Sinus Surgery (FESS) Instrument Kit
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 | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | OGR |
| Device type | Ear, Nose, And Throat Surgical Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-14 |
| Record revised | 2022-12-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MCLS40LP | In distribution | |
| MCLB2LP | In distribution | |
| MCLT00LP | In distribution | |
| MCL206LP | In distribution | |
| MCLS62LP | In distribution | |
| MCEN148LP | In distribution | |
| 106LP | In distribution | |
| MCO649LP | In distribution | |
| MCEN76LP | In distribution | |
| MCSK0LP | In distribution | |
| MCEN150LP | In distribution | |
| MCEN136LP | In distribution | |
| MCOH0LP | In distribution | |
| MCEN7600LP | 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 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 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.