Integra® Miltex®
Integra® Miltex® PESSARY RING WITH KNOB SIZE 3 WITHOUT SUPPORT
4manufacturers in China registered for this device type
189catalogue numbers in this listing
Who Else Makes It
All of them in Guangdong. 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| B&A Precision Silicone Rubber (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Guangzhou Fame Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 1 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | HHW |
| Device type | Pessary, Vaginal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.3575 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K013289 |
| Record published | 2016-08-26 |
| Record revised | 2024-12-20 (version 10) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30-GD6 | Size 6 (3.00″ OD) | In distribution |
| 30-D2 | Size 2 (2.50″ OD) | In distribution |
| 30-DSH6 | Size 6 (80 MM) | In distribution |
| 30-CUD8 | Size 8 (63 MM) | In distribution |
| 30-HDS3 | Size 3 (80 MM) | In distribution |
| 30-DSHS7 | Size 7 (85 MM) | In distribution |
| 30-R6 | Size 6 (3.25″ OD) | In distribution |
| 30-GH2 | Size 2 (60 MM) | In distribution |
| 30-OV3 | Size 3 (2.50″ OD) | In distribution |
| 30-GD4 | Size 4 (2.50″ OD) | In distribution |
| 30-RKS6 | Size 6 (3.25″ OD) | In distribution |
| 30-SH8 | Size 8 (3.50″ OD) | In distribution |
| 30-HD6 | Size 6 (95 MM) | In distribution |
| 30-GD5 | Size 5 (2.75″ OD) | In distribution |
| 30-CP0 | Size 0 (50 MM) | In distribution |
| 30-RS3 | Size 3 (2.50″ OD) | In distribution |
| 30-GH8 | Size 8 (90 MM) | In distribution |
| 30-DSH3 | Size 3 (65 MM) | In distribution |
| 30-GS0 | Size 0 (1.50″ OD) | In distribution |
| 30-RS1 | Size 1 (2.00″ OD) | In distribution |
| 30-CP6 | Size 6 (80 MM) | In distribution |
| 30-D4 | Size 4 (3.00″ OD) | In distribution |
| 30-HDS4 | Size 4 (85 MM) | In distribution |
| 30-SH6 | Size 6 (3.00″ OD) | In distribution |
| 30-DSHS4 | Size 4 (70 MM) | In distribution |
| 30-SH0 | Size 0 (1.50″ OD) | In distribution |
| 30-HD8 | Size 8 (105 MM) | In distribution |
| 30-MS2 | Size 2 (2.25″ OD) | In distribution |
| 30-M5 | Size 5 (3.00″ OD) | In distribution |
| 30-CUD9 | Size 9 (70 MM) | In distribution |
| 30-D1 | Size 1 (2.25″ OD) | In distribution |
| 30-CU3 | Size 3 (37 MM) | In distribution |
| 30-RK3 | Size 3 (2.50″ OD) | In distribution |
| 30-D7 | Size 7 (3.75″ OD) | In distribution |
| 30-D0 | Size 0 (2.00″ OD) | In distribution |
| 30-RKS2 | Size 2 (2.25″ OD) | In distribution |
| 30-DSHS6 | Size 6 (80 MM) | In distribution |
| 30-HDS0 | Size 0 (65 MM) | In distribution |
| 30-RS0 | Size 0 (1.75″ OD) | In distribution |
| 30-SH4 | Size 4 (2.50″ OD) | In distribution |
| 30-RK1 | Size 1 (2.00″ OD) | In distribution |
| 30-GS1 | Size 1 (1.75″ OD) | In distribution |
| 30-HDS6 | Size 6 (95 MM) | In distribution |
| 30-D3 | Size 3 (2.75″ OD) | In distribution |
| 30-CU4 | Size 4 (41 MM) | In distribution |
| 30-HDS8 | Size 8 (105 MM) | In distribution |
| 30-RK2 | Size 2 (2.25″ OD) | In distribution |
| 30-CPS0 | Size 0 (50 MM) | In distribution |
| 30-MS5 | Size 5 (3.00″ OD) | In distribution |
| 30-OVS2 | Size 2 (2.25″ OD) | In distribution |
| 30-DSH7 | Size 7 (85 MM) | In distribution |
| 30-OV9 | Size 9 (4.00″ OD) | In distribution |
| 30-M4 | Size 4 (2.75″ OD) | In distribution |
| 30-SH7 | Size 7 (3.25″ OD) | In distribution |
| 30-RKS5 | Size 5 (3.00″ OD) | In distribution |
| 30-CP1 | Size 1 (55 MM) | In distribution |
| 30-RKS7 | Size 7 (3.50″ OD) | In distribution |
| 30-DSHS1 | Size 1 (55 MM) | In distribution |
| 30-GS4 | Size 4 (2.50″ OD) | In distribution |
| 30-RS6 | Size 6 (3.25″ OD) | In distribution |
| 30-CU0 | Size 0 (25 MM) | In distribution |
| 30-DSH4 | Size 4 (70 MM) | In distribution |
| 30-SH3 | Size 3 (2.25″ OD) | In distribution |
| 30-CPS3 | Size 3 (65 MM) | In distribution |
| 30-GD0 | Size 0 (1.50″ OD) | In distribution |
| 30-GD7 | Size 7 (3.25″ OD) | In distribution |
| 30-RKS0 | Size 0 (1.75″ OD) | In distribution |
| 30-HDS2 | Size 2 (75 MM) | In distribution |
| 30-MS7 | Size 7 (3.50″ OD) | In distribution |
| 30-CUD91 | Size 10 (75MM) | In distribution |
| 30-GS5 | Size 5 (2.75″ OD) | In distribution |
| 30-GS3 | Size 3 (2.25″ OD) | In distribution |
| 30-RS5 | Size 5 (3.00″ OD) | In distribution |
| 30-HD5 | Size 5 (90 MM) | In distribution |
| 30-M6 | Size 6 (3.25″ OD) | In distribution |
| 30-CU7 | Size 7 (56 MM) | In distribution |
| 30-CUD0 | Size 0 (25 MM) | In distribution |
| 30-DSHS3 | Size 3 (65 MM) | In distribution |
| 30-CUD5 | Size 5 (45 MM) | In distribution |
| 30-MS4 | Size 4 (2.75″ OD) | In distribution |
| 30-CP5 | Size 5 (75 MM) | In distribution |
| 30-RK0 | Size 0 (1.75″ OD) | In distribution |
| 30-OVS1 | Size 1 (2.00″ OD) | In distribution |
| 30-GH5 | Size 5 (75 MM) | In distribution |
| 30-RS9 | Size 9 (4.00″ OD) | In distribution |
| 30-HD7 | Size 7 (100 MM) | In distribution |
| 30-RK5 | Size 5 (3.00″ OD) | In distribution |
| 30-CPS2 | Size 2 (60 MM) | In distribution |
| 30-HDS1 | Size 1 (70 MM) | In distribution |
| 30-OV4 | Size 4 (2.75″ OD) | In distribution |
| 30-GH4 | Size 4 (70 MM) | In distribution |
| 30-HDS7 | Size 7 (100 MM) | In distribution |
| 30-CU5 | Size 5 (45 MM) | In distribution |
| 30-GH6 | Size 6 (80 MM) | In distribution |
| 30-M7 | Size 7 (3.50″ OD) | In distribution |
| 30-CU6 | Size 6 (50 MM) | In distribution |
| 30-R4 | Size 4 (2.75″ OD) | In distribution |
| 30-CU8 | Size 8 (63 MM) | In distribution |
| 30-R5 | Size 5 (3.00″ OD) | In distribution |
| 30-GD3 | Size 3 (2.25″ OD) | In distribution |
| 30-HD0 | Size 0 (65 MM) | In distribution |
| 30-SH1 | Size 1 (1.75″ OD) | In distribution |
| 30-CU91 | Size 10 (75 MM) | In distribution |
| 30-OV1 | Size 1 (2.00″ OD) | In distribution |
| 30-CUD4 | Size 4 (41 MM) | In distribution |
| 30-RKS1 | Size 1 (2.00″ OD) | In distribution |
| 30-DSH2 | Size 2 (60 MM) | In distribution |
| 30-M8 | Size 8 (3.75″ OD) | In distribution |
| 30-R8 | Size 8 (3.75″ OD) | In distribution |
| 30-GH1 | Size 1 (55 MM) | In distribution |
| 30-CPS7 | Size 7 (85 MM) | In distribution |
| 30-MS3 | Size 3 (2.50″ OD) | In distribution |
| 30-RKS4 | Size 4 (2.75″ OD) | In distribution |
| 30-R7 | Size 7 (3.50″ OD) | In distribution |
| 30-MS6 | Size 6 (3.25″ OD) | In distribution |
| 30-RK4 | Size 4 (2.75″ OD) | In distribution |
| 30-CPS5 | Size 5 (75 MM) | In distribution |
| 30-D6 | Size 6 (3.50″ OD) | In distribution |
| 30-OVS3 | Size 3 (2.50″ OD) | In distribution |
| 30-DSHS2 | Size 2 (60 MM) | In distribution |
| 30-R1 | Size 1 (2.00″ OD) | In distribution |
| 30-900 | 7″ | In distribution |
| 30-CP7 | Size 7 (85 MM) | In distribution |
| 30-R0 | Size 0 (1.75″ OD) | In distribution |
| 30-HDS5 | Size 5 (90 MM) | In distribution |
| 30-CUD1 | Size 1 (29 MM) | In distribution |
| 30-GD8 | Size 8 (3.50″ OD) | In distribution |
| 30-OV6 | Size 6 (3.25″ OD) | In distribution |
| 30-FS1000 | In distribution | |
| 30-CPS1 | Size 1 (55 MM) | In distribution |
| 30-RS7 | Size 7 (3.50″ OD) | In distribution |
| 30-OVS7 | Size 7 (3.50″ OD) | In distribution |
| 30-DSH1 | Size 1 (55 MM) | In distribution |
| 30-OVS9 | Size 9 (4.00″ OD) | In distribution |
| 30-OVS4 | Size 4 (2.75″ OD) | In distribution |
| 30-RKS3 | Size 3 (2.50″ OD) | In distribution |
| 30-CUD2 | Size 2 (33 MM) | In distribution |
| 30-SH2 | Size 2 (2.00″ OD) | In distribution |
| 30-GS2 | Size 2 (2.00″ OD) | In distribution |
| 30-CU9 | Size 9 (70 MM) | In distribution |
| 30-HD3 | Size 3 (80 MM) | In distribution |
| 30-CP4 | Size 4 (70 MM) | In distribution |
| 30-SH5 | Size 5 (2.75″ OD) | In distribution |
| 30-RK6 | Size 6 (3.25″ OD) | In distribution |
| 30-RS2 | Size 2 (2.25″ OD) | In distribution |
| 30-GH7 | Size 7 (85 MM) | In distribution |
| 30-CU2 | Size 2 (33 MM) | In distribution |
| 30-M2 | Size 2 (2.25″ OD) | In distribution |
| 30-GH9 | Size 9 (95 MM) | In distribution |
| 30-D5 | Size 5 (3.25″ OD) | In distribution |
| 30-GS6 | Size 6 (3.00″ OD) | In distribution |
| 30-OVS5 | Size 5 (3.00″ OD) | In distribution |
| 30-HD1 | Size 1 (70 MM) | In distribution |
| 30-CUD7 | Size 7 (56 MM) | In distribution |
| 30-HD2 | Size 2 (75 MM) | In distribution |
| 30-GH3 | Size 3 (65 MM) | In distribution |
| 30-HD9 | Size 9 (110 MM) | In distribution |
| 30-OV5 | Size 5 (3.00″ OD) | In distribution |
| 30-R2 | Size 2 (2.25″ OD) | In distribution |
| 30-GS7 | Size 7 (3.25″ OD) | In distribution |
| 30-GD2 | Size 2 (2.00″ OD) | In distribution |
| 30-R3 | Size 3 (2.50″ OD) | In distribution |
| 30-CUD6 | Size 6 (50 MM) | In distribution |
| 30-HD4 | Size 4 (85 MM) | In distribution |
| 30-GS8 | Size 8 (3.50″ OD) | In distribution |
| 30-M3 | Size 3 (2.50″ OD) | In distribution |
| 30-CPS4 | Size 4 (70 MM) | In distribution |
| 30-GD1 | Size 1 (1.75″ OD) | In distribution |
| 30-OV2 | Size 2 (2.25″ OD) | In distribution |
| 30-OV8 | Size 8 (3.75″ OD) | In distribution |
| 30-CU1 | Size 1 (29 MM) | In distribution |
| 30-OV7 | Size 7 (3.50″ OD) | In distribution |
| 30-CP2 | Size 2 (60 MM) | In distribution |
| 30-R9 | Size 9 (4.00″ OD) | In distribution |
| 30-DSH0 | Size 0 (50 MM) | In distribution |
| 30-RS8 | Size 8 (3.75″ OD) | In distribution |
| 30-CUD3 | Size 3 (37 MM) | In distribution |
| 30-MS8 | Size 8 (3.75″ OD) | In distribution |
| 30-GH0 | Size 0 (50 MM) | In distribution |
| 30-CP3 | Size 3 (65 MM) | In distribution |
| 30-CPS6 | Size 6 (80 MM) | In distribution |
| 30-DSHS5 | Size 5 (75 MM) | In distribution |
| 30-OVS8 | Size 8 (3.75″ OD) | In distribution |
| 30-RS4 | Size 4 (2.75″ OD) | In distribution |
| 30-DSHS0 | Size 0 (50 MM) | In distribution |
| 30-HDS9 | Size 9 (110 MM) | In distribution |
| 30-RK7 | Size 7 (3.50″ OD) | In distribution |
| 30-DSH5 | Size 5 (75 MM) | In distribution |
| 30-OVS6 | Size 6 (3.25″ OD) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pessary, Vaginal | Panpac Medical Corporation | 628 |
| Milex | Coopersurgical, Inc. | 592 |
| Bioteque America, Inc. | Bioteque America, Inc. | 221 |
| Bioteque | Bioteque Taiwan Ltd. | 209 |
| HNM Women Care | HNM Stainless, LLC. | 187 |
| Medline | Medline Industries, Inc. | 162 |
| Marina Medical | Marina Medical Instruments, Inc. | 144 |
| EvaCare | Personal Medical Corp. | 128 |
| Hayden Medical | Hayden Medical Inc | 81 |
| Premier | Premier Dental Products Co. | 58 |
| LTL Medical | Bioteque Taiwan Ltd. | 56 |
| Sklar® | Sklar Corporation | 37 |
Showing 12 of 180. All products under Pessary, Vaginal
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.