JEDMED
- Primary DI
- M6335329030
- Brand
- JEDMED
- Company
- JEDMED INSTRUMENT COMPANY
- Model
- 53-2903
- Catalog number
- 53-2903
- Device description
- TROCAR & CANNULA SINUS 2.7MM
- Published
- 2020-09-21
- 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
Related Records
Product Codes
| Code | Name |
|---|---|
| KBG | Trocar, Sinus |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| KBG | Trocar, Sinus | Ear, Nose, Throat | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| M6335329030 | Primary | HIBCC | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| ENT trocar blade | A rigid, surgical instrument with a sharp pyramidal or conical point used to puncture body cavities during ear/nose/throat (ENT) surgery. It can be assembled and used together with a compatible cannula (not included) filling its lumen, thereby allowing the introduction of this assembly; following puncture, the trocar blade is withdrawn. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 092987189
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- 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
- true
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 |
|---|---|---|---|---|
| 00888118131294 | LEVEL ONE TRANSBUCCAL | KLS-Martin L.P. | KBG | 2022-02-22 |
| 00888118131300 | LEVEL ONE TRANSBUCCAL | KLS-Martin L.P. | KBG | 2022-02-22 |
| M6335325050 | JEDMED | JEDMED INSTRUMENT COMPANY | KBG | 2020-09-21 |
| M6335325290 | JEDMED | JEDMED INSTRUMENT COMPANY | KBG | 2020-09-21 |
| 00888118041289 | LEVEL ONE TRANSBUCCAL | KLS-Martin L.P. | KBG | 2020-06-19 |
| 00888118041340 | LEVEL ONE TRANSBUCCAL | KLS-Martin L.P. | KBG | 2020-06-19 |
| 00888118041357 | LEVEL ONE TRANSBUCCAL | KLS-Martin L.P. | KBG | 2020-06-19 |
| 00888118041371 | LEVEL ONE TRANSBUCCAL | KLS-Martin L.P. | KBG | 2020-06-19 |
| 00888118041623 | LEVEL ONE TRANSBUCCAL | KLS-Martin L.P. | KBG | 2020-06-19 |
| 00888118041630 | LEVEL ONE TRANSBUCCAL | KLS-Martin L.P. | KBG | 2020-06-19 |
| 00888118041678 | LEVEL ONE TRANSBUCCAL | KLS-Martin L.P. | KBG | 2020-06-19 |
| 00888118071958 | TROCAR | KLS-Martin L.P. | KBG | 2018-09-26 |
| 00888118073402 | LEVEL ONE | KLS-Martin L.P. | KBG | 2018-09-26 |
| 00888118090300 | LEVEL ONE | KLS-Martin L.P. | KBG | 2018-09-26 |
| 00888118090324 | LEVEL ONE | KLS-Martin L.P. | KBG | 2018-09-26 |
| 00888118097217 | LEVEL ONE | KLS-Martin L.P. | KBG | 2018-09-26 |
| 00888118097644 | LEVEL ONE | KLS-Martin L.P. | KBG | 2018-09-26 |
| 00888118119162 | LEVEL ONE | KLS-Martin L.P. | KBG | 2018-09-26 |
| 00888118004895 | LEVEL ONE TRANSBUCCAL | KLS-Martin L.P. | KBG | 2018-09-26 |
| 00888118006790 | LEVEL ONE TRANSBUCCAL | KLS-Martin L.P. | KBG | 2018-09-26 |
| 00888118006806 | LEVEL ONE TRANSBUCCAL | KLS-Martin L.P. | KBG | 2018-09-26 |
| 00888118006899 | LEVEL ONE TRANSBUCCAL | KLS-Martin L.P. | KBG | 2018-09-26 |
| 00888118006905 | LEVEL ONE TRANSBUCCAL | KLS-Martin L.P. | KBG | 2018-09-26 |
| 00888118073396 | LEVEL ONE TRANSBUCCAL | KLS-Martin L.P. | KBG | 2018-09-26 |
| 00888118074966 | LEVEL ONE TRANSBUCCAL | KLS-Martin L.P. | KBG | 2018-09-26 |
| 00888118076847 | LEVEL ONE TRANSBUCCAL | KLS-Martin L.P. | KBG | 2018-09-26 |
| 00888118090263 | LEVEL ONE TRANSBUCCAL | KLS-Martin L.P. | KBG | 2018-09-26 |
| 00888118090287 | LEVEL ONE TRANSBUCCAL | KLS-Martin L.P. | KBG | 2018-09-26 |
| 00888118117922 | LEVEL ONE TRANSBUCCAL | KLS-Martin L.P. | KBG | 2018-09-26 |
| 00888118117984 | LEVEL ONE TRANSBUCCAL | KLS-Martin L.P. | KBG | 2018-09-26 |