PENTAX Medical
- Primary DI
- 04580826926945
- Brand
- PENTAX Medical
- Company
- PENTAX MEDICAL CORPORATION
- Model
- OF-B53
- Device description
- Suction Control Valve
- Published
- 2026-08-25
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes#
Code, Name table| Code | Name |
|---|
| FAM | sigmoidoscope and accessories, flexible/rigid |
Product Code Classifications#
Code, Device, Specialty table| Code | Device | Specialty | Class |
|---|
| FAM | Sigmoidoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 2 |
Identifiers And Packaging#
Identifier, Type, Agency table| Identifier | Type | Agency | Package quantity | Status |
|---|
| 04580826926945 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
Source identifier, GTIN-14 normalized, EAN-13 table| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 04580826926945 | 04580826926945 | 4580826926945 |
Sterilization Methods#
Method table| Method |
|---|
| Ethylene Oxide |
| High-level Disinfectant |
| Sound Waves |
Regulatory Flags#
- DUNS number
- 691559848
- 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
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company#
Other Devices Sharing Product Codes#
Primary DI, Brand, Company table| Primary DI | Brand | Company | Product code | Published |
|---|
| 04580826927058 | PENTAX Medical | PENTAX MEDICAL CORPORATION | FAM | 2026-08-25 |
| 04580826928611 | PENTAX Medical | PENTAX MEDICAL CORPORATION | FAM | 2026-08-25 |
| 00732094139051 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FAM | 2023-08-18 |
| 00732094139075 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FAM | 2023-08-18 |
| 00732094080940 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FAM | 2023-08-17 |
| 00732094080957 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FAM | 2023-08-17 |
| 00732094080964 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FAM | 2023-08-17 |
| 04961333115303 | PENTAX | HOYA CORPORATION | FAM | 2023-07-31 |
| 04547410436501 | FUJIFILM | FUJIFILM CORPORATION | FAM | 2021-04-27 |
| 00732094080384 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FAM | 2021-04-26 |
| 00732094080391 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FAM | 2021-04-14 |
| 00732094200300 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FAM | 2020-01-16 |
| 00732094079678 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FAM | 2018-03-01 |
| 00732094080933 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FAM | 2018-03-01 |
| 04961333070831 | PENTAX | HOYA CORPORATION | FAM | 2017-04-07 |
| 04961333071425 | PENTAX | HOYA CORPORATION | FAM | 2017-04-07 |
| 04961333228164 | PENTAX | HOYA CORPORATION | FAM | 2017-04-07 |
| 04961333232635 | VIDEO SIGMOIDOSCOPE | PENTAX OF AMERICA, INC. | FAM | 2017-04-06 |
| 04961333232642 | VIDEO SIGMOIDOSCOPE | PENTAX OF AMERICA, INC. | FAM | 2017-04-06 |
| 04547410330977 | FUJIFILM | FUJIFILM CORPORATION | FAM | 2016-12-14 |
| 04547410333299 | FUJIFILM | FUJIFILM CORPORATION | FAM | 2016-12-14 |
| 04048551084373 | n.a. | Karl Storz GmbH & Co. KG | FAM | 2016-09-23 |
| 00732094236958 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FAM | 2016-09-20 |
| 00732094144024 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FAM | 2016-09-20 |
| 00732094106046 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FAM | 2016-09-19 |
| 00732094106060 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FAM | 2016-09-17 |
| 00732094144000 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FAM | 2016-09-17 |
| 00749756173520 | DeRoyal | DEROYAL INDUSTRIES, INC. | FAM | 2016-09-12 |
| 50749756173525 | DeRoyal | DEROYAL INDUSTRIES, INC. | FAM | 2016-09-12 |