Elmed
Garrett vascular dilators. Thin shaft with elongated oval tip. Matte and mirror finish. Set of nine dilators, 1mm to 5mm increasing in 0.5mm increments, and holder. Overall length 8-1/8in…
Garrett vascular dilators. Thin shaft with elongated oval tip. Matte and mirror finish. Set of nine dilators, 1mm to 5mm increasing in 0.5mm increments, and holder. Overall length 8-1/8in (20.6cm).
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
| Huaian Wolfram Surgical Instruments | Huaian | Jiangsu | Manufacturer | 14 |
| Global Medical Production Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Elmed, Inc., United States |
|---|---|
| FDA product code | DWS |
| Device type | Instruments, Surgical, Cardiovascular |
| Device class | Class 1 |
| Regulation | 21 CFR 870.4500 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-08-30 |
| Record revised | 2024-11-04 (version 2) |
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, manufacturing date |
| Distribution end date | 2024-11-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 24400G | In distribution | |
| 24265-11-OLY2 | In distribution | |
| 24195-82 | In distribution | |
| SPTB-175 | In distribution | |
| 1162-L | In distribution | |
| 60-3503S | In distribution | |
| ST245590152 | In distribution | |
| ST2426511OLY1 | In distribution | |
| EL-CH5580 | In distribution | |
| 24229-50-06 | In distribution | |
| 24-PVT0300 | In distribution | |
| 24-PVT0700 | In distribution | |
| 60-3500s | In distribution | |
| 24229-8C025 | In distribution | |
| 24-PVT0500 | In distribution | |
| ST2426505OLY2 | In distribution | |
| 24229-06 | In distribution | |
| ST242296008 | In distribution | |
| ST242295006 | In distribution | |
| 24101-413 | In distribution | |
| ST242296025 | In distribution | |
| 24265-05-OLY2 | In distribution | |
| 24-712443 | In distribution | |
| 24-PVT0400 | In distribution | |
| 24400E | In distribution | |
| 24245-12 | In distribution | |
| 24229-06025 | In distribution | |
| ST2422906B | In distribution | |
| ST242296006 | In distribution | |
| 24229-60-06 | In distribution | |
| 24229-SC25H | In distribution | |
| ST247125 | In distribution | |
| ST2426505OLY1 | In distribution | |
| 37-6740-30 | In distribution | |
| 24-PVT0200 | In distribution | |
| 2471-25 | In distribution | |
| ST242295008 | In distribution | |
| 24-PVT1000 | In distribution | |
| 24195-98 | In distribution | |
| 24229-08025 | In distribution | |
| ST2490146 | In distribution | |
| 24229-50-08 | In distribution | |
| ST2424512 | In distribution | |
| 24195-91 | In distribution | |
| 24229-08B | In distribution | |
| 24265-13-OLY1 | In distribution | |
| ST24600A | In distribution | |
| 24600A | In distribution | |
| 24195-93 | In distribution | |
| 24-1207-SR | In distribution | |
| 24101-411 | In distribution | |
| ST1162L | In distribution | |
| 24-CV5050 | In distribution | |
| 24229-6C025 | In distribution | |
| 24229-06B | In distribution | |
| AR-13 | In distribution | |
| ST2422908B | In distribution | |
| ST2422906 | In distribution | |
| 24229-6025 | In distribution | |
| 24195-99 | In distribution | |
| ST2422960H | In distribution | |
| 24229-60-H | In distribution | |
| 24-5590-152 | In distribution | |
| 24-PVT0350 | In distribution | |
| ST241010 | In distribution | |
| 24-1010 | In distribution | |
| 24229-FC25H | In distribution | |
| 24-3116 | In distribution | |
| 24422-41 | In distribution | |
| ST2422950H | In distribution | |
| 24400H | In distribution | |
| ST24712443 | In distribution | |
| 24-PVT0900 | In distribution | |
| 24101-412 | In distribution | |
| 24229-50-H | In distribution | |
| 24195-92 | In distribution | |
| ST2422906025 | In distribution | |
| 60-3501M | In distribution | |
| ST2426513OLY1 | In distribution | |
| 24400F | In distribution | |
| 24-PVT0600 | In distribution | |
| ST2426511OLY2 | In distribution | |
| 24-3112 | In distribution | |
| 24-258009 | In distribution | |
| 24420-41 | In distribution | |
| ST2422908025 | In distribution | |
| 24901-46 | In distribution | |
| 24-PVT0800 | In distribution | |
| 24265-11-OLY1 | In distribution | |
| 24265-05-OLY1 | In distribution | |
| 24195-81 | In distribution | |
| 24229-60-08 | In distribution | |
| 24195-83 | In distribution | |
| 24282-32 | Withdrawn | |
| 24265-11-OLY2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Delacroix-Chevalier | Landanger | 1,819 |
| Landanger | Landanger | 1,213 |
| Ambler Surgical | Ambler Surgical, LLC | 1,013 |
| Pilling | Teleflex Medical LLC | 971 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 876 |
| V. Mueller | Steris Corporation | 716 |
| Novo Surgical | Novo Surgical, Inc. | 387 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 364 |
| Instruments, Surgical, Cardiovascular | Fehling Instruments GmbH | 352 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 290 |
| Avalign | Avalign Technologies, Inc. | 283 |
| Millennium | Avalign Technologies, Inc. | 272 |
Showing 12 of 472. All products under Instruments, Surgical, Cardiovascular
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.