Centurion
Vaginal Delivery Instrument Pack
1manufacturer
159catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Record
| Listed by | Centurion Medical Products Corporation, United States |
|---|---|
| FDA product code | MLS |
| Device type | Labor And Delivery Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Premarket notification | Exempt |
| Record published | 2016-11-11 |
| Record revised | 2019-01-15 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 0 to 32 °C |
| Packaging | Case of 5, case of 6, case of 10, case of 20, case of 4, case of 12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MNS5272 | In distribution | |
| MNS12425A | In distribution | |
| MNS5425 | In distribution | |
| OR1905 | In distribution | |
| MNS5530 | In distribution | |
| MNS3505 | In distribution | |
| MNS5200 | In distribution | |
| MNS7515 | In distribution | |
| MNS8780 | In distribution | |
| M2066 | In distribution | |
| MNS12425 | In distribution | |
| MNS5245 | In distribution | |
| MNS9020 | In distribution | |
| MNS11230 | In distribution | |
| MNS5615 | In distribution | |
| MNS6930 | In distribution | |
| MNS11535 | In distribution | |
| MNS5630 | In distribution | |
| MNS8950 | In distribution | |
| MNS7460 | In distribution | |
| MNS10350 | In distribution | |
| OR1626 | In distribution | |
| MNS9835 | In distribution | |
| SUT12850 | In distribution | |
| OR2010 | In distribution | |
| MNS6496 | In distribution | |
| MNS9315 | In distribution | |
| MNS12085 | In distribution | |
| MNS10565 | In distribution | |
| OR2005 | In distribution | |
| MNS8790 | In distribution | |
| MNS10995 | In distribution | |
| MNS8080 | In distribution | |
| MNS4660 | In distribution | |
| MNS4215 | In distribution | |
| MNS5495A | In distribution | |
| MNS9815 | In distribution | |
| MNS3135 | In distribution | |
| MNS10795 | In distribution | |
| OR1821 | In distribution | |
| SUT10695 | In distribution | |
| MNS4205 | In distribution | |
| MNS11040 | In distribution | |
| MNS10995 | In distribution | |
| MNS8570 | In distribution | |
| MNS4230 | In distribution | |
| MNS5495B | In distribution | |
| MNS4490 | In distribution | |
| MNS11020 | In distribution | |
| MNS5000 | In distribution | |
| W232 | In distribution | |
| MNS10995 | In distribution | |
| MNS9480A | In distribution | |
| C259 | In distribution | |
| MNS6745 | In distribution | |
| MNS8770 | In distribution | |
| MNS8170 | In distribution | |
| MNS10905 | In distribution | |
| MNS3860A | In distribution | |
| MNS12385 | In distribution | |
| MNS4900 | In distribution | |
| MNS6940 | In distribution | |
| MNS2925B | In distribution | |
| SUT18560 | In distribution | |
| MNS4030 | In distribution | |
| MNS6090 | In distribution | |
| MNS6240 | In distribution | |
| PE3610 | In distribution | |
| MNS4755 | In distribution | |
| OR1905 | In distribution | |
| OR1490 | In distribution | |
| MNS11040A | In distribution | |
| MNS7300 | In distribution | |
| MNS5750A | In distribution | |
| MNS9410 | In distribution | |
| MNS6395B | In distribution | |
| O197 | In distribution | |
| MNS4740A | In distribution | |
| MNS11475 | In distribution | |
| MNS2015 | In distribution | |
| MNS6130 | In distribution | |
| MNS12080 | In distribution | |
| OR1770 | In distribution | |
| MNS8970 | In distribution | |
| MNS7655 | In distribution | |
| MNS10640 | In distribution | |
| MNS8895 | In distribution | |
| MNS2420 | In distribution | |
| MNS10140 | In distribution | |
| MNS2860 | In distribution | |
| MNS3515 | In distribution | |
| MNS11020A | In distribution | |
| MNS10875A | In distribution | |
| MNS9975 | In distribution | |
| MNS1085 | In distribution | |
| MNS12510 | In distribution | |
| MNS10265 | In distribution | |
| MNS10930 | In distribution | |
| MNS6050 | In distribution | |
| MNS9825 | In distribution | |
| MNS5725 | In distribution | |
| MNS5410 | In distribution | |
| MNS2615 | In distribution | |
| MNS10985 | In distribution | |
| MNS9455 | In distribution | |
| MNS6630 | In distribution | |
| MNS10530 | In distribution | |
| MNS4550A | In distribution | |
| MNS7380 | In distribution | |
| MNS9480 | In distribution | |
| PE5400 | In distribution | |
| MNS3355 | In distribution | |
| MNS3440 | In distribution | |
| MNS2040 | In distribution | |
| OR1821A | In distribution | |
| MNS4740 | In distribution | |
| U375 | In distribution | |
| MNS12515 | In distribution | |
| MNS10770 | In distribution | |
| MNS10875 | In distribution | |
| MNS12830 | In distribution | |
| MNS4605 | In distribution | |
| MNS6920 | In distribution | |
| MNS6395 | In distribution | |
| MNS5575 | In distribution | |
| MNS10990 | In distribution | |
| MNS4820 | In distribution | |
| MNS2885 | In distribution | |
| MNS7895 | In distribution | |
| MNS12680 | In distribution | |
| MNS2925A | In distribution | |
| MNS5495 | In distribution | |
| MNS12730 | In distribution | |
| MNS13090 | In distribution | |
| MNS4175 | In distribution | |
| MNS3190 | In distribution | |
| MNS10515 | In distribution | |
| MNS4770 | In distribution | |
| MNS11840A | In distribution | |
| MNS3715A | In distribution | |
| MNS6330 | In distribution | |
| MNS9455 R01 | In distribution | |
| CC200 | In distribution | |
| OR1685A | In distribution | |
| SUT17965 | In distribution | |
| MNS11265 | In distribution | |
| MNS8945 | In distribution | |
| MNS6395A | In distribution | |
| MNS12975 | In distribution | |
| MNS10545 | In distribution | |
| MNS12285 | In distribution | |
| MNS12050 | In distribution | |
| MNS6710 | In distribution | |
| MNS3135 R01 | In distribution | |
| MNS10565 R01 | In distribution | |
| MNS8950A | In distribution | |
| OR1821C | In distribution | |
| OR900 | In distribution | |
| MNS5255 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 3,909 |
| Medline Industries, Inc. | Medline Industries, Inc. | 3,405 |
| ACS | American Contract Systems, Inc. | 244 |
| Regard™ | ROi CPS LLC | 125 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 63 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 29 |
| Aligned Medical Solutions | Aligned Medical Solutions | 16 |
| Medical Action Industries | Medical Action Industries, Inc. | 11 |
| Medline | Medline Industries, Inc. | 6 |
| Halyard | Avid Medical, Inc. | 6 |
| Devon | Cardinal Health | 4 |
| Instrapac | Robinson Healthcare Limited | 4 |
Showing 12 of 16. All products under Labor And Delivery Kit
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Under Investigation by firm | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 27320 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Process control | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 29192 |
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.