Integra® Miltex®
Integra® Miltex® Hank Uterine Dilator 10-1/2", Double-Ended, Set of 6, 9Fr/10Fr thru 19Fr/20Fr, in Green Canvas Roll
3manufacturers in China registered for this device type
100catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Zhejiang (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 |
| Wenzhou LW Wewear Accessories Co., Ltd. | Wenzhou | Zhejiang | Private-label distributor | 2 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | HDQ |
| Device type | Dilator, Cervical, Fixed Size |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-02-26 |
| Record revised | 2025-03-12 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 68 to 77 °F; Storage environment temperature 20 to 25 °C |
| Sizes | Outer diameter 4.3 to 14.3 mm; catheter gauge 13 to 43 Fr |
| Distribution end date | 2022-05-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 30-530-85 | In distribution | ||
| 30-505-2122 | In distribution | ||
| 30-560-4143 | Outer Diameter 13.5 mm | In distribution | |
| 30-530-3 | In distribution | ||
| 30-560-2123 | Outer Diameter 7 mm | In distribution | |
| 30-530-13 | In distribution | ||
| 30-500 | In distribution | ||
| 30-520 | In distribution | ||
| 30-505-2526 | In distribution | ||
| 30-530-115 | In distribution | ||
| 30-505-2930 | In distribution | ||
| 30-530-105 | In distribution | ||
| MH30-505-910 | In distribution | ||
| MH30-561 | 11-1/2″ | In distribution | |
| 30-530-45 | In distribution | ||
| 30-530-4 | In distribution | ||
| 30-530-18 | In distribution | ||
| 30-5002 | 25 | In distribution | |
| 30-530-25 | In distribution | ||
| MH30-560-2123 | Outer Diameter 7.5 mm | In distribution | |
| 30-555-910 | In distribution | ||
| 30-560-1315 | Outer Diameter 4.3 mm | In distribution | |
| 30-530-8 | In distribution | ||
| 30-505-2324 | In distribution | ||
| 30-560-2527 | Catheter Gauge 25 Fr | In distribution | |
| MH30-505-1112 | In distribution | ||
| MH30-550 | In distribution | ||
| 30-555-34 | In distribution | ||
| 30-530-150 | In distribution | ||
| MH30-500 | In distribution | ||
| MH30-555-78 | In distribution | ||
| MH30-560-3335 | Outer Diameter 11 mm | In distribution | |
| 30-560-3335 | Outer Diameter 11 mm | In distribution | |
| 30-560-2931 | Outer Diameter 10.3 mm | In distribution | |
| 30-505-1112 | In distribution | ||
| MH30-555-910 | In distribution | ||
| 30-530-2 | In distribution | ||
| 30-505-2728 | In distribution | ||
| MH30-505-1314 | In distribution | ||
| 30-505-910 | In distribution | ||
| 30-530-21 | In distribution | ||
| 30-530-95 | In distribution | ||
| MH30-560-2931 | 11-1/2″ | In distribution | |
| 30-555-56 | In distribution | ||
| 30-555-1718 | In distribution | ||
| MH30-555-1314 | In distribution | ||
| 30-515 | In distribution | ||
| 30-530-250 | In distribution | ||
| 30-560-3739 | 11-1/2″ | In distribution | |
| MH30-560-1315 | Outer Diameter 4.3 mm | In distribution | |
| MH30-555-56 | In distribution | ||
| 30-530-24 | In distribution | ||
| 30-505-1920 | In distribution | ||
| 30-530-65 | In distribution | ||
| MH30-560-1719 | Catheter Gauge 17 Fr | In distribution | |
| 30-530-15 | In distribution | ||
| MH30-560-3739 | Outer Diameter 13 mm | In distribution | |
| MH30-555-1112 | In distribution | ||
| MH30-555-1516 | In distribution | ||
| 30-530-16 | In distribution | ||
| 30-530-35 | In distribution | ||
| 30-555-1516 | In distribution | ||
| 30-5001 | 25 | In distribution | |
| 30-555-1112 | In distribution | ||
| 30-530-75 | In distribution | ||
| 30-555-1314 | In distribution | ||
| 30-505-1516 | In distribution | ||
| MH30-505-1516 | In distribution | ||
| 30-555-78 | In distribution | ||
| 30-3000 | In distribution | ||
| 30-530-22 | In distribution | ||
| 30-530-1 | In distribution | ||
| MH30-505-1920 | In distribution | ||
| MH30-555-1718 | In distribution | ||
| 30-530-19 | In distribution | ||
| 30-530-6 | In distribution | ||
| 30-530-9 | In distribution | ||
| 30-505-1314 | In distribution | ||
| MH30-555-34 | In distribution | ||
| 30-530-10 | In distribution | ||
| 30-530-7 | In distribution | ||
| 30-505-78 | In distribution | ||
| 30-530-20 | In distribution | ||
| 30-530-17 | In distribution | ||
| 30-530-55 | In distribution | ||
| 30-530-11 | In distribution | ||
| 30-560-1719 | Catheter Gauge 17 Fr | In distribution | |
| 30-561 | In distribution | ||
| 30-530-12 | In distribution | ||
| 30-550 | In distribution | ||
| 30-505-1718 | In distribution | ||
| MH30-505-1718 | In distribution | ||
| 30-530-23 | In distribution | ||
| 30-530-125 | In distribution | ||
| MH30-560-2527 | 11-1/2″ | In distribution | |
| 30-530-14 | In distribution | ||
| 30-530-5 | In distribution | ||
| 30-530-26 | In distribution | ||
| 30-530-165 | Withdrawn | ||
| 30-530-135 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hayden Medical | Hayden Medical Inc | 184 |
| Millennium | Avalign Technologies, Inc. | 181 |
| Elmed Incorporated | Elmed, Inc. | 152 |
| Marina Medical | Marina Medical Instruments, Inc. | 142 |
| Elmed | Elmed, Inc. | 138 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 129 |
| Ambler Surgical | Ambler Surgical, LLC | 103 |
| Aesculap | Aesculap AG | 98 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 77 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 73 |
| V. Mueller | Steris Corporation | 65 |
| Quinelato | Schobell Industrial Ltda | 55 |
Showing 12 of 104. All products under Dilator, Cervical, Fixed Size
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.