Bioteque
- Primary DI
- 04719894430034
- Brand
- Bioteque
- Company
- Bioteque Taiwan Ltd.
- Model
- R4
- Published
- 2024-12-06
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| HHW | Pessary, Vaginal |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HHW | Pessary, Vaginal | Obstetrics/Gynecology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K092981 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04719894430034 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04719894430034 | 04719894430034 | 4719894430034 |
GMDN Terms#
| Term | Definition |
|---|---|
| Pelvic-organ-supporting pessary | A device made of rubber or soft plastics designed for insertion into the vagina to hold the uterus, bladder and/or rectum in place and help prevent prolapse (falling or sliding of the organ from its normal position into the pelvic cavity), either as a permanent or temporary treatment; it is not dedicated to bladder-only support. It is available in a variety of shapes (e.g., rings, stems) and sizes; it may be fitted for each woman individually. This is a reusable device after appropriate cleaning. |
Regulatory Flags#
- DUNS number
- 657769858
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04719894432434 | Bioteque | OS265BA-1 | 2024-04-08 | |
| 04719894432441 | Bioteque | OS265BA-2 | 2024-04-08 | |
| 04719894432458 | Bioteque | OS265BA-3 | 2024-04-08 | |
| 04719894432571 | Bioteque | BA05F | 2024-04-08 | |
| 04719894432588 | Bioteque | BA07F | 2024-04-08 | |
| 04719894432595 | Bioteque | BA051F | 2024-04-08 | |
| 04719894432601 | Bioteque | BA071F | 2024-04-08 | |
| 04719894432618 | Bioteque | BA05F-ST | 2024-04-08 | |
| 04719894432625 | Bioteque | BA001 | 2024-04-08 | |
| 04719894432755 | Bioteque | UIC5F | 2024-04-08 | |
| 04719894432762 | Bioteque | UIC5FA | 2024-04-08 | |
| 04719894432779 | Bioteque | UIC5FAX | 2024-04-08 | |
| 04719894432847 | Bioteque | BA100 | 2024-04-08 | |
| 04719894432878 | Bioteque | UMI4.5 | 2024-04-08 | |
| 04719894432892 | Bioteque | UMI4.5C | 2024-12-06 | |
| 04719894432908 | Bioteque | UMI4.5KC | 2024-12-06 | |
| 04719894432915 | Bioteque | UMI4.5K-G | 2024-12-06 | |
| 04719894432922 | Bioteque | UMI4.5-P | 2024-12-06 | |
| 04719894432939 | Bioteque | UI 4.0 | 2024-04-08 | |
| 04719894433363 | Bioteque | RD003-P | 2024-04-08 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 09903124199524 | CNTRL+ Bladder Support Pessary | Cntrl+ Inc. | HHW | 2026-02-22 |
| 04719894430003 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894430010 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894430584 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894430591 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894430904 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894430911 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894430928 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894430935 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894430942 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894430959 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894430966 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894430973 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894430980 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894430997 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894431000 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894431017 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894431024 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894431031 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894431048 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894431055 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894431062 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894431079 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894431086 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894431093 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894431109 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894431116 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894431123 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894431130 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |
| 04719894431147 | Bioteque | Bioteque Taiwan Ltd. | HHW | 2024-12-06 |