Integra® Miltex®
Integra® Miltex® West Lacrimal Sac Gouge, 6-1/4", 4mm Wide Blade, Straight
4manufacturers in China registered for this device type
28catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | GDH |
| Device type | Gouge, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-01-10 |
| Record revised | 2024-12-09 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 7 to 8 in; width 4 to 6 mm; width 1 in |
| Distribution end date | 2023-12-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 27-466C | 3/4″ Wide | In distribution |
| 27-280 | In distribution | |
| 20-274 | Width 6 mm | In distribution |
| 19-785 | In distribution | |
| 27-549 | Length 8 in | In distribution |
| 27-462 | 1/2″ wide | In distribution |
| PM-4417 | In distribution | |
| 19-770 | In distribution | |
| 27-550 | 3/8 Inch Width | In distribution |
| 27-466 | 3/4″ wide | In distribution |
| 27-556 | Width 1 in | In distribution |
| 19-774 | In distribution | |
| 18-404 | In distribution | |
| 18-1964 | 6-1/4″ | In distribution |
| 27-458C | 1/4″ Wide | In distribution |
| 18-376 | In distribution | |
| 27-464C | 5/8″ Wide | In distribution |
| 27-460C | 9-3/4″ | In distribution |
| 27-458 | 9-3/4″ | In distribution |
| 19-784 | In distribution | |
| 27-551 | 1/2 Inch Width | In distribution |
| PM-4419 | In distribution | |
| 19-776 | In distribution | |
| PM-7595 | 6.5mm Blade | In distribution |
| 40-79 | In distribution | |
| 27-553 | 5/8 Inch Width | In distribution |
| 19-772 | In distribution | |
| 27-460 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 206 |
| Ambler Surgical | Ambler Surgical, LLC | 164 |
| Life Instruments | Life Instrument Corp. | 131 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 103 |
| Surtex | Surtex Instruments Ltd | 95 |
| Novo Surgical | Novo Surgical, Inc. | 89 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 86 |
| Aesculap | Aesculap AG | 82 |
| gSource | Gsource, LLC. | 71 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 64 |
| Orthomed | Ortho-MED, Inc. | 60 |
| Boss Instruments | Boss Instruments, Ltd. | 53 |
Showing 12 of 77. All products under Gouge, Surgical, General & Plastic Surgery
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.