JEDMED
- Primary DI
- M63370X65150
- Brand
- JEDMED
- Company
- JEDMED INSTRUMENT COMPANY
- Model
- 70X6515
- Catalog number
- 70X6515
- Device description
- STROBOCAM II PLATFORM ONLY
- Published
- 2023-02-06
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes#
| Code | Name |
|---|---|
| EQL | Laryngostroboscope |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| EQL | Laryngostroboscope | Ear, Nose, Throat | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| M63370X65150 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Laryngostroboscope | A device that is intended to allow the observation of glottic action during phonation (speech) in the examination of voice disorders. The device operates by focusing a stroboscopic light through a lens for direct or mirror reflected viewing of glottic action. It can contain a microphone that captures the acoustic signals from the glottic area and may or may not contact the patient. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 092987189
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| M6332904600 | JEDMED | 29-0460 | 29-0460 | 2022-12-19 |
| M6335824200 | JEDMED | 58-2420 | 58-2420 | 2023-01-19 |
| M6334942100 | JEDMED | 49-4210 | 49-4210 | 2016-12-14 |
| M6334942130 | JEDMED | 49-4213 | 49-4213 | 2016-12-14 |
| M6334942170 | JEDMED | 49-4217 | 49-4217 | 2016-12-14 |
| M6334942200 | JEDMED | 49-4220 | 49-4220 | 2016-12-14 |
| M6334942230 | JEDMED | 49-4223 | 49-4223 | 2016-12-14 |
| M6334942270 | JEDMED | 49-4227 | 49-4227 | 2016-12-14 |
| M6334943000 | JEDMED | 49-4300 | 49-4300 | 2016-12-14 |
| M6334943030 | JEDMED | 49-4303 | 49-4303 | 2016-12-14 |
| M633494303A0 | JEDMED | 49-4303 A | 49-4303 A | 2016-12-14 |
| M6334943040 | JEDMED | 49-4304 | 49-4304 | 2016-12-14 |
| M6334943070 | JEDMED | 49-4307 | 49-4307 | 2016-12-14 |
| M6334943100 | JEDMED | 49-4310 | 49-4310 | 2016-12-14 |
| M633494310W0 | JEDMED | 49-4310 W | 49-4310 W | 2016-12-14 |
| M6334943130 | JEDMED | 49-4313 | 49-4313 | 2016-12-14 |
| M633494313A0 | JEDMED | 49-4313 A | 49-4313 A | 2016-12-14 |
| M633494313W0 | JEDMED | 49-4313 W | 49-4313 W | 2016-12-14 |
| M6334943170 | JEDMED | 49-4317 | 49-4317 | 2016-12-14 |
| M6334944100 | JEDMED | 49-4410 | 49-4410 | 2016-12-14 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 04961333255016 | LARYNGOSTROBOSCOPE | PENTAX OF AMERICA, INC. | EQL | 2025-04-25 |
| 04961333255702 | LARYNGOSTROBOSCOPE | PENTAX OF AMERICA, INC. | EQL | 2025-04-25 |
| 04961333255719 | LARYNGOSTROBOSCOPE | PENTAX OF AMERICA, INC. | EQL | 2025-04-25 |
| 04961333255726 | LARYNGOSTROBOSCOPE | PENTAX OF AMERICA, INC. | EQL | 2025-04-25 |
| 04048551327074 | NA | Karl Storz GmbH & Co. KG | EQL | 2025-03-28 |
| 04250365156034 | ATMOS | ATMOS MedizinTechnik GmbH & Co. KG | EQL | 2024-11-27 |
| 04250365167832 | ATMOS | ATMOS MedizinTechnik GmbH & Co. KG | EQL | 2024-11-27 |
| 08436041580256 | Optomic | OPTOMIC ESPAÑA SA | EQL | 2024-07-17 |
| 08436041580263 | Optomic | OPTOMIC ESPAÑA SA | EQL | 2024-07-17 |
| 00848657070218 | Laryngostroboscope | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | EQL | 2023-10-12 |
| 04961333128174 | PENTAX | HOYA CORPORATION | EQL | 2023-07-31 |
| 04042761069663 | Olympus | OLYMPUS Winter & Ibe GmbH | EQL | 2023-06-20 |
| 04042761069670 | Olympus | OLYMPUS Winter & Ibe GmbH | EQL | 2023-06-20 |
| 04580137730279 | MACHIDA | MACHIDA ENDOSCOPE CO.,LTD. | EQL | 2023-06-09 |
| M6334949910 | JEDMED | JEDMED INSTRUMENT COMPANY | EQL | 2023-05-09 |
| M6337064050 | JEDMED | JEDMED INSTRUMENT COMPANY | EQL | 2023-02-07 |
| M63370640510 | JEDMED | JEDMED INSTRUMENT COMPANY | EQL | 2023-02-07 |
| M63370640520 | JEDMED | JEDMED INSTRUMENT COMPANY | EQL | 2023-02-07 |
| M63370640710 | JEDMED | JEDMED INSTRUMENT COMPANY | EQL | 2023-02-07 |
| M63370640720 | JEDMED | JEDMED INSTRUMENT COMPANY | EQL | 2023-02-07 |
| M63370640730 | JEDMED | JEDMED INSTRUMENT COMPANY | EQL | 2023-02-07 |
| M63370640740 | JEDMED | JEDMED INSTRUMENT COMPANY | EQL | 2023-02-07 |
| M63370640750 | JEDMED | JEDMED INSTRUMENT COMPANY | EQL | 2023-02-07 |
| M63370640760 | JEDMED | JEDMED INSTRUMENT COMPANY | EQL | 2023-02-07 |
| M6337064100 | JEDMED | JEDMED INSTRUMENT COMPANY | EQL | 2023-02-07 |
| M6337064250 | JEDMED | JEDMED INSTRUMENT COMPANY | EQL | 2023-02-07 |
| M6337064300 | JEDMED | JEDMED INSTRUMENT COMPANY | EQL | 2023-02-07 |
| M63370643010 | JEDMED | JEDMED INSTRUMENT COMPANY | EQL | 2023-02-07 |
| M63370643020 | JEDMED | JEDMED INSTRUMENT COMPANY | EQL | 2023-02-07 |
| M6337064350 | JEDMED | JEDMED INSTRUMENT COMPANY | EQL | 2023-02-07 |