Elmed
MEDICAL GRADE CUSTOM CLEAN CAST ACYLIC VAGINAL DIALATOR PROBE WITH GENTLE SMOOTH CURVED TIP FOR COMFORATBLE INSERTION AND BASE WITH GROOVES ON HANDLE FOR MEASURING AND ANTI - SLIP CONTROL -…
MEDICAL GRADE CUSTOM CLEAN CAST ACYLIC VAGINAL DIALATOR PROBE WITH GENTLE SMOOTH CURVED TIP FOR COMFORATBLE INSERTION AND BASE WITH GROOVES ON HANDLE FOR MEASURING AND ANTI – SLIP CONTROL – 1″ DIAMETER X 13″ OVERALL LENGTH-Reusable/Autoclavable
3manufacturers in China registered for this device type
138catalogue 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 | Elmed, Inc., United States |
|---|---|
| FDA product code | HDQ |
| Device type | Dilator, Cervical, Fixed Size |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-04-17 |
| Record revised | 2024-11-04 (version 3) |
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, serial number |
| Distribution end date | 2024-11-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 31-1450-002 | In distribution | |
| SM32281-205 | In distribution | |
| 71410-32 | In distribution | |
| 31-4016 | In distribution | |
| 71410-20 | In distribution | |
| 32-5004-I | In distribution | |
| SM-23410-03 | In distribution | |
| 51503-88XL | In distribution | |
| 31-1401-005 | In distribution | |
| 31-4028 | In distribution | |
| EL-GL1450-003 | In distribution | |
| 32-3342 | In distribution | |
| SM-23410-11 | In distribution | |
| 32-26-02 | In distribution | |
| SM-23410-18 | In distribution | |
| 31-4030 | In distribution | |
| SM-23410-20 | In distribution | |
| 31-1450-002 | In distribution | |
| 71410-18 | In distribution | |
| EL-GL1471-002 | In distribution | |
| 32-26-18 | In distribution | |
| 32201-32 | In distribution | |
| 32-30-14 | In distribution | |
| 32-26-26 | In distribution | |
| SM-23410-10 | In distribution | |
| 71410-26 | In distribution | |
| 31-1450-015 | In distribution | |
| 32-26-30 | In distribution | |
| EL-GL1471-003 | In distribution | |
| 31-1401-004 | In distribution | |
| 31-1450-012 | In distribution | |
| 32-5001-I | In distribution | |
| 32-23-19/20 | In distribution | |
| EL-GL1450-002 | In distribution | |
| EL-GL1401-007 | In distribution | |
| 31-1401-009 | In distribution | |
| EL-GL1401-006 | In distribution | |
| 32-3343 | In distribution | |
| 31-1404-0095 | In distribution | |
| 31-1401-007 | In distribution | |
| 31-4022 | In distribution | |
| 32-26-04 | In distribution | |
| 31-1450-01 | In distribution | |
| EL-GL1450-007 | In distribution | |
| SM-23410-08 | In distribution | |
| 32-26-24 | In distribution | |
| EL-GL1401-002 | In distribution | |
| SM32281-165 | In distribution | |
| SM-23410-09 | In distribution | |
| ST311401010 | In distribution | |
| EL-GL1411-002 | In distribution | |
| 31-4024 | In distribution | |
| SM-23410-14 | In distribution | |
| 13-523280-1.5 | In distribution | |
| 31-1401-0095 | In distribution | |
| 31-1401-003 | In distribution | |
| 32-30-12 | In distribution | |
| 32-26-22 | In distribution | |
| SM32281-105 | In distribution | |
| 31-1450-010 | In distribution | |
| 71567-26 | In distribution | |
| 32-26-14 | In distribution | |
| SM-23410-16 | In distribution | |
| EL-GL1471-006 | In distribution | |
| 31-1401-010 | In distribution | |
| SM32281-145 | In distribution | |
| EL-GL1450-004 | In distribution | |
| 31-1450-011 | In distribution | |
| 32-26-10 | In distribution | |
| EL-GL1401-004 | In distribution | |
| EL-GL1401-008 | In distribution | |
| SM-23410-07 | In distribution | |
| 32-23-22 | In distribution | |
| 31-1450-013 | In distribution | |
| 71410-28 | In distribution | |
| 31-1401-012 | In distribution | |
| SM-23410-12 | In distribution | |
| SM32281-125 | In distribution | |
| 31-4018 | In distribution | |
| EL-GL1471-004 | In distribution | |
| 32-5003-I | In distribution | |
| SM-23410-22 | In distribution | |
| 32-26-06 | In distribution | |
| EL-GL1471-001 | In distribution | |
| 32-3339SM-J | In distribution | |
| 71410-30 | In distribution | |
| 32-26-08 | In distribution | |
| 31-1450-016 | In distribution | |
| 32-3341 | In distribution | |
| 31-1450-004 | In distribution | |
| EL-GL1450-001 | In distribution | |
| 32-26-20 | In distribution | |
| 31-4020 | In distribution | |
| EL-GL1450-008 | In distribution | |
| 31-1450-008 | In distribution | |
| 31-4026 | In distribution | |
| 71410-22 | In distribution | |
| SM-23410-05 | In distribution | |
| SM-23410-04 | In distribution | |
| 32-26-28 | In distribution | |
| 31-1450-006 | In distribution | |
| 31-1450-005 | In distribution | |
| 31-1450-003 | In distribution | |
| 32-30-10 | In distribution | |
| 32-26-12 | In distribution | |
| 32-3340 | In distribution | |
| 31-1450-007 | In distribution | |
| 31-1450-009 | In distribution | |
| 32-5005-I | In distribution | |
| 32-30-18 | In distribution | |
| SM-23410-24 | In distribution | |
| SM-23410-28 | In distribution | |
| EL-GL1411-001 | In distribution | |
| 31-1450-001 | In distribution | |
| 32-5002-I | In distribution | |
| EL-GL1450-005 | In distribution | |
| 32-30-16 | In distribution | |
| 32-26-16 | In distribution | |
| EL-GL1471-005 | In distribution | |
| 31-1401-006 | In distribution | |
| SM-23410-30 | In distribution | |
| 32-347-32 | In distribution | |
| SM-23410-06 | In distribution | |
| 32-26-32 | In distribution | |
| 32-30-20 | In distribution | |
| 31-1450-014 | In distribution | |
| SM-23410-26 | In distribution | |
| 31-1401-013 | In distribution | |
| 51503-86XL | In distribution | |
| 71410-24 | In distribution | |
| SM32281-185 | In distribution | |
| EL-GL1450-006 | In distribution | |
| 31-1401-008 | In distribution | |
| EL-GL1401-001 | In distribution | |
| 31-1450-010 | Withdrawn | |
| 31-1450-012 | Withdrawn | |
| 31-1450-011 | Withdrawn | |
| 31-1450-009 | 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 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 129 |
| Ambler Surgical | Ambler Surgical, LLC | 103 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 100 |
| 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.