Novo Surgical Inc.
hegar uterine dilator, single ended, 7 1/4" (18.5 cm), set of 11, sizes 1.0 mm to 6.0 mm (whole & half sizes), in canvas roll
3manufacturers in China registered for this device type
129catalogue 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 | Novo Surgical, Inc., United States |
|---|---|
| FDA product code | HDQ |
| Device type | Dilator, Cervical, Fixed Size |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2022-11-11 |
| Record revised | 2024-02-02 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2024-02-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OB6346-36 | In distribution | |
| OB6340-21 | In distribution | |
| OB6346-24 | In distribution | |
| OB6341-13 | In distribution | |
| OB6342-15 | In distribution | |
| OB96348-28 | In distribution | |
| OB6346-22 | In distribution | |
| OB6371-21 | In distribution | |
| OB6342-13 | In distribution | |
| OB6371-10 | In distribution | |
| OB6346-28 | In distribution | |
| OB6371-24 | In distribution | |
| OB6342-18 | In distribution | |
| OB6347-10 | In distribution | |
| OB6347-72 | In distribution | |
| OB6347-56 | In distribution | |
| OB6371-26 | In distribution | |
| OB6341-19 | In distribution | |
| OB6341-34 | In distribution | |
| OB6341-31 | In distribution | |
| OB6347-28 | In distribution | |
| OB6342-25 | In distribution | |
| OB6348-26 | In distribution | |
| OB6342-19 | In distribution | |
| OB6347-36 | In distribution | |
| OB6341-33 | In distribution | |
| OB6341-35 | In distribution | |
| OB6348-28 | In distribution | |
| OB6348-22 | In distribution | |
| OB6348-38 | In distribution | |
| OB6341-37 | In distribution | |
| OB6346-26 | In distribution | |
| OB6347-68 | In distribution | |
| OB6347-24 | In distribution | |
| OB6348-24 | In distribution | |
| OB6341-22 | In distribution | |
| OB6341-17 | In distribution | |
| OB6347-44 | In distribution | |
| OB6341-18 | In distribution | |
| OB96347-32 | In distribution | |
| OB6342-26 | In distribution | |
| OB6341-15 | In distribution | |
| OB6371-15 | In distribution | |
| OB6341-29 | In distribution | |
| OB6346-32 | In distribution | |
| OB6346-16 | In distribution | |
| OB96347-30 | In distribution | |
| OB6341-16 | In distribution | |
| OB6348-30 | In distribution | |
| OB6342-10 | In distribution | |
| OB6341-24 | In distribution | |
| OB6341-10 | In distribution | |
| OB6347-64 | In distribution | |
| OB96347-28 | In distribution | |
| OB6346-18 | In distribution | |
| OB6347-76 | In distribution | |
| OB6348-16 | In distribution | |
| OB6342-23 | In distribution | |
| OB6346-11 | In distribution | |
| OB6341-12 | In distribution | |
| OB6346-10 | In distribution | |
| OB6342-22 | In distribution | |
| OB6347-84 | In distribution | |
| OB6346-14 | In distribution | |
| OB6342-12 | In distribution | |
| OB6348-10 | In distribution | |
| OB6347-88 | In distribution | |
| OB6348-14 | In distribution | |
| OB6342-16 | In distribution | |
| OB6341-21 | In distribution | |
| OB96348-26 | In distribution | |
| OB6371-22 | In distribution | |
| OB6347-52 | In distribution | |
| OB96348-24 | In distribution | |
| OB6347-53 | In distribution | |
| OB6347-50 | In distribution | |
| OB6346-20 | In distribution | |
| OB6348-18 | In distribution | |
| OB6371-11 | In distribution | |
| OB6371-29 | In distribution | |
| OB6342-14 | In distribution | |
| OB6371-17 | In distribution | |
| OB6341-36 | In distribution | |
| OB6347-48 | In distribution | |
| OB6342-28 | In distribution | |
| OB6348-36 | In distribution | |
| OB6348-53 | In distribution | |
| OB6371-18 | In distribution | |
| OB96347-44 | In distribution | |
| OB6346-12 | In distribution | |
| OB96348-20 | In distribution | |
| OB6371-16 | In distribution | |
| OB6346-30 | In distribution | |
| OB6341-11 | In distribution | |
| OB6341-26 | In distribution | |
| OB6347-70 | In distribution | |
| OB6341-14 | In distribution | |
| OB6346-38 | In distribution | |
| OB6346-53 | In distribution | |
| OB6371-23 | In distribution | |
| OB6347-32 | In distribution | |
| OB6371-25 | In distribution | |
| OB6341-28 | In distribution | |
| OB6302-20 | In distribution | |
| OB6347-30 | In distribution | |
| OB96347-36 | In distribution | |
| OB6342-29 | In distribution | |
| OB6340-22 | In distribution | |
| OB96348-22 | In distribution | |
| OB96347-52 | In distribution | |
| OB6342-27 | In distribution | |
| OB96348-10 | In distribution | |
| OB6371-28 | In distribution | |
| OB6341-20 | In distribution | |
| OB6371-27 | In distribution | |
| OB96347-48 | In distribution | |
| OB6371-14 | In distribution | |
| OB6302-31 | In distribution | |
| OB6342-17 | In distribution | |
| OB96347-24 | In distribution | |
| OB6371-19 | In distribution | |
| OB6346-34 | In distribution | |
| OB6348-32 | In distribution | |
| OB6348-34 | In distribution | |
| OB6341-27 | In distribution | |
| OB6348-20 | In distribution | |
| OB6342-21 | In distribution | |
| OB6341-23 | In distribution | |
| OB6347-56 | 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 |
| 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.