American Medicals
- Primary DI
- B356JB132000
- Brand
- American Medicals
- Company
- American Medicals
- Model
- 1
- Published
- 2023-05-31
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
Product Codes#
| Code | Name |
|---|---|
| HDF | Speculum, Vaginal, Metal |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| B356JB132000 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Vaginal speculum, reusable | A hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened at an angle. It is typically made of stainless steel. This is a reusable device. |
Sterilization Methods#
| Method |
|---|
| Microwave Radiation |
Regulatory Flags#
- DUNS number
- 109909627
- Device count
- 1
- Premarket exempt
- true
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| B35675400020 | American Medicals | 1 | 2026-05-20 | |
| B35675440110 | American Medicals | 1 | 2026-05-20 | |
| B356BH414050 | American Medicals | 1 | 2026-05-06 | |
| B356KB074090 | American Medicals | 1 | 2026-05-06 | |
| B356KF251020 | American Medicals | 1 | 2026-04-15 | |
| B356KF251040 | American Medicals | 1 | 2026-04-15 | |
| B356ED469970 | American Medicals | 1 | 2026-04-07 | |
| B356ED470040 | American Medicals | 1 | 2026-04-07 | |
| B356ED470050 | American Medicals | 1 | 2026-04-07 | |
| B356JD259280 | American Medicals | 1 | 2026-03-09 | |
| B356JB543320 | American Medicals | 1 | 2026-02-26 | |
| B356JB641170 | American Medicals | 1 | 2026-02-06 | |
| B356DF370170 | American Medicals | 1 | 2026-01-30 | |
| B356BK905180 | American Medicals | 1 | 2026-01-27 | |
| B356FH454070 | American Medical | 1 | 2025-12-10 | |
| B356FH455060 | American Medicals | 1 | 2025-12-10 | |
| B356ED107160 | American Medicals | 1 | 2025-12-03 | |
| B356JB536280 | American Medicals | 1 | 2025-11-25 | |
| B356BK211150 | American Medicals | 1 | 2025-11-10 | |
| B356DF410180 | American Medicals | 1 | 2025-11-10 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 10649111067235 | Sklar Instruments | SKLAR CORPORATION | HDF | 2025-03-18 |
| 10649111067624 | Sklar Instruments | SKLAR CORPORATION | HDF | 2025-03-18 |
| 10649111068966 | Sklar Instruments | SKLAR CORPORATION | HDF | 2025-03-18 |
| 10649111069345 | Sklar Instruments | SKLAR CORPORATION | HDF | 2025-03-18 |
| 10649111069574 | Sklar Instruments | SKLAR CORPORATION | HDF | 2025-03-18 |
| 10649111069888 | Sklar Instruments | SKLAR CORPORATION | HDF | 2025-03-18 |
| G586OB631721NCDT0 | Novo Surgical | NOVO SURGICAL, INC. | HDF | 2024-02-22 |
| G586OB631723NCDT0 | Novo Surgical | NOVO SURGICAL, INC. | HDF | 2024-02-22 |
| G586OB633804NC0 | Novo Surgical | NOVO SURGICAL, INC. | HDF | 2024-02-22 |
| 10653160294153 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | HDF | 2022-01-02 |
| 10653160294122 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | HDF | 2022-01-01 |
| 10653160294948 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | HDF | 2022-01-01 |
| 10653160306528 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | HDF | 2022-01-01 |
| 10381780495024 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | HDF | 2018-10-24 |
| 10381780495031 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | HDF | 2018-10-24 |
| 10381780495048 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | HDF | 2018-10-24 |
| 10381780495055 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | HDF | 2018-10-24 |
| 10381780495062 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | HDF | 2018-10-24 |
| 10381780495147 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | HDF | 2018-10-24 |
| 10649111392276 | Sklar® | SKLAR CORPORATION | HDF | 2018-09-24 |
| 10649111392283 | Sklar® | SKLAR CORPORATION | HDF | 2018-09-24 |
| 10381780500490 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | HDF | 2018-09-18 |
| 10381780500506 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | HDF | 2018-09-18 |
| 10381780500513 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | HDF | 2018-09-18 |
| 10381780500520 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | HDF | 2018-09-18 |
| 10381780500537 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | HDF | 2018-09-18 |
| 10381780500544 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | HDF | 2018-09-18 |
| 10381780500551 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | HDF | 2018-09-18 |
| 10381780500582 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | HDF | 2018-09-18 |
| 10381780500599 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | HDF | 2018-09-18 |