Marina Medical
Vaginal-Pediatric (C)-Four Sizes Smaller Length: 50mm Larger Size:75mm ,Smaller OD-s:9.5mm ,Larger OD-s:13.5mm , Smaller OD-L: 13mm Larger OD-L:18mm
3manufacturers in China registered for this device type
142catalogue numbers in this listing
2recalls on this code
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 | Marina Medical Instruments, Inc., United States |
|---|---|
| FDA product code | HDQ |
| Device type | Dilator, Cervical, Fixed Size |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-05-08 |
| Record revised | 2025-03-13 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number |
| Sizes | Length 1 to 40 cm; width 2.54 to 4.44 cm; length 5.5 to 22 mm; length 8.5 to 12 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 260-333XL | In distribution | ||
| 260-159 | In distribution | ||
| 260-117 | Length 19 cm | In distribution | |
| 220-334 | Length 13 cm | In distribution | |
| 260-115 | Length 19 cm | In distribution | |
| 260-363 | Length 29 cm | In distribution | |
| 220-318 | Length 13 cm | In distribution | |
| 270-009 | Width 2.54 cm | In distribution | |
| 260-155 | In distribution | ||
| 260-413 | Length 7.5 cm | In distribution | |
| 260-612 | 25 | In distribution | |
| 260-357 | Length,29,cm | In distribution | |
| 260-158 | In distribution | ||
| 260-411 | Length 7.5 cm | In distribution | |
| 260-166 | Length 8.5 mm | In distribution | |
| 260-020 | In distribution | ||
| 260-150 | In distribution | ||
| 260-349 | Length 29 cm | In distribution | |
| 260-100M | Length 19 cm | In distribution | |
| 260-601A | Length 8.5 in | In distribution | |
| 260-123 | Length 19 cm | In distribution | |
| 260-211 | In distribution | ||
| 260-109 | Length 19 cm | In distribution | |
| 260-150A | In distribution | ||
| 260-317XL | In distribution | ||
| 260-313XL | In distribution | ||
| 260-161 | In distribution | ||
| 270-405 | Length 10 in | In distribution | |
| 260-313 | Length 29 cm | In distribution | |
| 270-202 | In distribution | ||
| 270-003 | Width 2.54 cm | In distribution | |
| 270-000 | In distribution | ||
| 260-207 | Length 26 cm | In distribution | |
| 260-221 | Length,26,cm | In distribution | |
| 260-129 | Length 19 cm | In distribution | |
| 260-105 | Length 19 cm | In distribution | |
| 260-412 | Length 7.5 cm | In distribution | |
| 260-127 | Length 19 cm | In distribution | |
| 260-172 | Length 1.2 cm | In distribution | |
| 260-362 | Length 29 cm | In distribution | |
| 260-152 | In distribution | ||
| 260-111 | Length 19 cm | In distribution | |
| 260-329 | Length 29 cm | In distribution | |
| 260-010 | In distribution | ||
| 260-329XL | In distribution | ||
| 260-361 | Length,29,cm | In distribution | |
| 270-303XL | Length 40 cm | In distribution | |
| 260-176 | Length 22 mm | In distribution | |
| 260-317 | Length 29 cm | In distribution | |
| 260-157 | In distribution | ||
| 260-107 | Length 19 cm | In distribution | |
| 260-209 | Length 26 cm | In distribution | |
| 270-015 | Width 2.54 cm | In distribution | |
| 260-165 | Length 8 mm | In distribution | |
| 260-151 | In distribution | ||
| 270-303 | In distribution | ||
| 270-201 | In distribution | ||
| 270-412 | In distribution | ||
| 260-217 | Length 26 cm | In distribution | |
| 220-330 | Length 13 cm | In distribution | |
| 260-105XL | Length 19 cm | In distribution | |
| 260-219 | Length 29 cm | In distribution | |
| 260-119 | Length 19 cm | In distribution | |
| 260-603A | Length 20 cm | In distribution | |
| 260-620 | In distribution | ||
| 260-131 | Length 19.1 cm | In distribution | |
| 260-101XL | Length 12 in | In distribution | |
| 350-273 | In distribution | ||
| 270-302 | In distribution | ||
| 220-324 | Length 13 cm | In distribution | |
| 220-326 | Length 13 cm | In distribution | |
| 260-171 | Length,26,cm | In distribution | |
| 220-338 | Length 13 cm | In distribution | |
| 220-336 | Length 13 cm | In distribution | |
| 260-168 | Length 9.5 mm | In distribution | |
| 220-332 | Length 13 cm | In distribution | |
| 260-365 | Length 29 cm | In distribution | |
| 220-322 | Length 13 cm | In distribution | |
| 260-160 | Length 5.5 mm | In distribution | |
| 260-603 | Length 20 cm | In distribution | |
| 220-328 | Length 13 cm | In distribution | |
| 260-103 | Length 19 cm | In distribution | |
| 260-153 | In distribution | ||
| 260-175 | Length 21 cm | In distribution | |
| 260-610A | In distribution | ||
| 260-345 | Length,29,cm | In distribution | |
| 260-169 | In distribution | ||
| 260-611 | 25 | In distribution | |
| 270-007 | Width 2.54 cm | In distribution | |
| 260-213 | Length 26 cm | In distribution | |
| 270-013 | Width 2.54 cm | In distribution | |
| 260-200 | Length 26 cm | In distribution | |
| 260-173 | Length 1 cm | In distribution | |
| 270-011 | Width 2.54 cm | In distribution | |
| 260-154 | In distribution | ||
| 260-353 | Length,29,cm | In distribution | |
| 260-130 | Length 19.1 cm | In distribution | |
| 260-325XL | In distribution | ||
| 260-229 | Length 26 cm | In distribution | |
| 260-337 | Length 29 cm | In distribution | |
| 220-300 | Length 13 cm | In distribution | |
| 260-113 | Length 19 cm | In distribution | |
| 260-225 | Length,26,cm | In distribution | |
| 260-601 | Length 20 cm | In distribution | |
| 220-320 | Length 13 cm | In distribution | |
| 260-301 | Length 29 cm | In distribution | |
| 270-017 | Width 4.44 cm | In distribution | |
| 220-314 | Length 13 cm | In distribution | |
| 260-101 | Length 19 cm | In distribution | |
| 260-341XL | In distribution | ||
| 270-401 | Length 32 cm | In distribution | |
| 340-250 | In distribution | ||
| 260-100 | Length 19 cm | In distribution | |
| 260-223 | Length,26,cm | In distribution | |
| 260-610 | Length 20 cm | 25 | In distribution |
| 260-364 | Length,29,cm | In distribution | |
| 260-300A | In distribution | ||
| 260-602 | Length 20 cm | In distribution | |
| 260-325 | Length 29 cm | In distribution | |
| 260-156 | In distribution | ||
| 260-321 | Length 29 cm | In distribution | |
| 220-312 | Length 13 cm | In distribution | |
| 260-333 | Length 29 cm | In distribution | |
| 260-501 | In distribution | ||
| 260-128 | Length 19 cm | In distribution | |
| 260-164 | Length 7.5 mm | In distribution | |
| 260-321XL | In distribution | ||
| 270-200 | In distribution | ||
| 260-414 | Length 7.5 cm | In distribution | |
| 260-227 | Length 26 cm | In distribution | |
| 260-126 | Length 19 cm | In distribution | |
| 260-341 | Length 29 cm | In distribution | |
| 260-163 | Length 7 mm | In distribution | |
| 270-304 | Length 32 cm | In distribution | |
| 270-303XL | Length 40 cm | In distribution | |
| 270-005 | Width 2.54 cm | In distribution | |
| 260-121 | Length 19 cm | In distribution | |
| 220-316 | Length 13 cm | In distribution | |
| 260-125 | Length,26,cm | In distribution | |
| 260-300 | Length,29,cm | In distribution | |
| 260-337XL | In distribution | ||
| 260-600 | Length 21.6 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hayden Medical | Hayden Medical Inc | 184 |
| Millennium | Avalign Technologies, Inc. | 181 |
| Elmed Incorporated | Elmed, Inc. | 152 |
| Elmed | Elmed, Inc. | 138 |
| 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
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-04-09 | Not classified | Nonconforming Material/Component | Marina Medical, Sunrise, FL initiated recall of 46 products of 350 series devices and 47 products of 270 series products because the material used to manufacture the products was not proven to be biocompatible, resulting in risk of tempora | 22 | 2010-09-03 |
| 2009-04-09 | Not classified | Nonconforming Material/Component | Marina Medical, Sunrise, FL initiated recall of 46 different 350 series devices and 47 different 270 series products because the material used to manufacture the products was not proven to be biocompatible, resulting in risk of temporary sk | 27 | 2010-09-03 |
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.