DenBite
- Primary DI
- 08717228440212
- Brand
- DenBite
- Company
- DuPhaMed B.V.
- Model
- DBU34ES
- Device description
- Hygienic sleeves for Cephalometric Earcone, LDPE
- Published
- 2023-11-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| EGZ | Holder, Film, X-Ray |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| EGZ | Holder, Film, X-Ray | Dental | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08717228440212 | Primary | GS1 | 0 | |
| 08717228441011 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08717228440212 | 08717228440212 | 8717228440212 |
| 08717228441011 | 08717228441011 | 8717228441011 |
GMDN Terms#
| Term | Definition |
|---|---|
| Medical equipment/instrument drape, single-use | A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device. |
Regulatory Flags#
- DUNS number
- 413491023
- Device count
- 150
- Premarket exempt
- true
- Lot or batch
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 08717228440113 | DenBite | DBBBLS | 2023-11-24 | |
| 08717228440120 | DenBite | DBU3001 | 2023-11-24 | |
| 08717228440137 | DenBite | DBS01 | 2023-11-24 | |
| 08717228440144 | DenBite | DBS02 | 2023-11-24 | |
| 08717228440366 | Cefla | CEF4060 | 97901860 | 2023-11-23 |
| 08717228440373 | Cefla | CEF4061 | 97901861 | 2023-11-23 |
| 08717228440380 | Cefla | CEF4062 | 97901862 | 2023-11-23 |
| 08717228440397 | Cefla | CEF4063 | 97901863 | 2023-11-23 |
| 08717228440403 | Cefla | CEF4064 | 96609347 | 2023-11-23 |
| 08717228440410 | Cefla | CEFQRBBLS | 97901484 | 2023-11-23 |
| 08717228440427 | Cefla | CEFS01 | 97901113 | 2023-11-23 |
| 08717228440434 | Cefla | CEFS02 | 97901114 | 2023-11-23 |
| 08717228440458 | Cefla | CEFFOAM | 97901557 | 2023-11-23 |
| 08717228440557 | Care Stream Dental | BDA32 | BDA32 | 2023-11-23 |
| 08717228440564 | Care Stream Dental | BDA33 | BDA33 | 2023-11-23 |
| 08717228440571 | Care Stream Dental | IX014 | IX014 | 2023-11-23 |
| 08717228440588 | Care Stream Dental | IX015 | IX015 | 2023-11-23 |
| 08717228440595 | Care Stream Dental | IX016 | IX016 | 2023-11-23 |
| 08717228442537 | Flow Dental | Earflow34 | 81500 | 2023-11-23 |
| 08717228442605 | Care Stream Dental | 7200 #0 | 5942503 | 2023-11-23 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 10371347019633 | Advance Dental Products | The Atlanta Dental Supply Company | EGZ | 2025-11-18 |
| 10304040192112 | Carina | HENRY SCHEIN, INC. | EGZ | 2025-05-13 |
| D00361765101 | Xios | Dentsply International Inc. | EGZ | 2024-11-06 |
| D00361765281 | Xios | Dentsply International Inc. | EGZ | 2024-11-06 |
| D00361765361 | Xios | Dentsply International Inc. | EGZ | 2024-11-06 |
| D00361765511 | Xios | Dentsply International Inc. | EGZ | 2024-11-06 |
| D003B10730511 | Universal | Dentsply International Inc. | EGZ | 2024-11-06 |
| D003B10730521 | Universal | Dentsply International Inc. | EGZ | 2024-11-06 |
| D003B10730531 | Universal | Dentsply International Inc. | EGZ | 2024-11-06 |
| D003B10730541 | Universal | Dentsply International Inc. | EGZ | 2024-11-06 |
| D003B10730551 | Universal | Dentsply International Inc. | EGZ | 2024-11-06 |
| 08717228440007 | DenBite | DuPhaMed B.V. | EGZ | 2023-11-24 |
| 08717228440014 | DenBite | DuPhaMed B.V. | EGZ | 2023-11-24 |
| 08717228440021 | DenBite | DuPhaMed B.V. | EGZ | 2023-11-24 |
| 08717228440113 | DenBite | DuPhaMed B.V. | EGZ | 2023-11-24 |
| 08717228440120 | DenBite | DuPhaMed B.V. | EGZ | 2023-11-24 |
| 08717228440137 | DenBite | DuPhaMed B.V. | EGZ | 2023-11-24 |
| 08717228440144 | DenBite | DuPhaMed B.V. | EGZ | 2023-11-24 |
| 08717228440168 | DenBite | DuPhaMed B.V. | EGZ | 2023-11-24 |
| 08717228440175 | DenBite | DuPhaMed B.V. | EGZ | 2023-11-24 |
| 08717228440182 | DenBite | DuPhaMed B.V. | EGZ | 2023-11-24 |
| 08717228440250 | Cefla | DuPhaMed B.V. | EGZ | 2023-11-23 |
| 08717228440281 | Cefla | DuPhaMed B.V. | EGZ | 2023-11-23 |
| 08717228440298 | Cefla | DuPhaMed B.V. | EGZ | 2023-11-23 |
| 08717228440366 | Cefla | DuPhaMed B.V. | EGZ | 2023-11-23 |
| 08717228440373 | Cefla | DuPhaMed B.V. | EGZ | 2023-11-23 |
| 08717228440380 | Cefla | DuPhaMed B.V. | EGZ | 2023-11-23 |
| 08717228440397 | Cefla | DuPhaMed B.V. | EGZ | 2023-11-23 |
| 08717228440403 | Cefla | DuPhaMed B.V. | EGZ | 2023-11-23 |
| 08717228440410 | Cefla | DuPhaMed B.V. | EGZ | 2023-11-23 |