FUJIFILM
- Primary DI
- 44547410435243
- Brand
- FUJIFILM
- Company
- FUJIFILM CORPORATION
- Model
- WB2517DC
- Device description
- This product is intended to clean the instrument/suction channel and accessories during pre-cleaning of a FUJIFILM endoscope.
- Published
- 2022-10-07
- 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
- true
Product Codes
| Code | Name |
|---|
| MNL | ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MNL | Accessories, Cleaning Brushes, For Endoscope | Gastroenterology, Urology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 44547410435243 | Package | GS1 | 10 | In Commercial Distribution |
| 34547410435246 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 44547410435243 | 44547410435243 |
| 34547410435246 | 34547410435246 |
GMDN Terms
| Term | Definition |
|---|
| Surgical instrument/endoscope cleaning utensil, single-use | A non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Atmospheric Pressure | 70 KiloPascal | 106 KiloPascal | |
| Handling Environment Humidity | 30 Percent (%) Relative Humidity | 85 Percent (%) Relative Humidity | |
| Handling Environment Temperature | 10 Degrees Celsius | 40 Degrees Celsius | |
| Special Storage Condition, Specify | 0 | 0 | There must be no condensation. |
| Storage Environment Atmospheric Pressure | 70 KiloPascal | 106 KiloPascal | |
| Storage Environment Humidity | 10 Percent (%) Relative Humidity | 85 Percent (%) Relative Humidity | |
| Storage Environment Temperature | -20 Degrees Celsius | 60 Degrees Celsius | |
Contacts
| Phone | Email |
|---|
| +018002728465 | xxx@xxx.xxx |
Regulatory Flags
- DUNS number
- 713565195
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- 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
- false
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|---|
| 04547410480269 | FUJIFILM | VS-1000 | | 2026-05-22 |
| 04547410529128 | FUJIFILM | EG-S100XT | | 2026-05-22 |
| 04573596200865 | APERTO Lucent | MR-JCR-82 | Joint coil (M) MR-JCR-82 for APERTO Lucent/APEROT | 2026-05-22 |
| 04573596200889 | APERTO Lucent | MR-JC-81 | Joint coil (S) MRJC-81 for APERTO Lucent/APERTO Et | 2026-05-22 |
| 04573596200896 | APERTO Lucent | MR-JCR-83 | Joint coil (L) MR-JCR-83 for APERTO Lucent/APEROT | 2026-05-22 |
| 04573596200902 | APERTO Lucent | MR-CSC-81 | C-Spine coil MR-SCS-81 for APERTO Lucent/APERTO Et | 2026-05-22 |
| 04573596200940 | APERTO Lucent | MR-QWC-81 | Wrist coil MR-QWC-81 for APERTO Lucent/Aperto Eter | 2026-05-22 |
| 04573596200964 | APERTO Lucent | MR-MSC-81 | Shoulder coil MR-MSC-81 for APERTO Lucent/APERTO E | 2026-05-22 |
| 04573596200971 | APERTO Lucent | MR-QRC-81 | Head coil (L) MR-QRC-81 for APERTO Lucent/APERTO E | 2026-05-22 |
| 04573596201480 | APERTO Lucent | MR-QHC-81R | QD Head coil R MR-QHC-81R for APERTO Lucent | 2026-05-22 |
| 04573596201497 | APERTO Lucent | MR-QKC-83R | QD Knee coil R MR-QKC-83R for APERTO Lucent | 2026-05-22 |
| 04573596201503 | APERTO Lucent | MR-IBC-83 | Open body coil MR-IBC-83 for APERTO Lucent/APERTO | 2026-05-22 |
| 04573596202210 | APERTO Lucent | MR-QFC-82N | Flexible Body coil N(M) MR-QFC-82N for APERTO Luce | 2026-05-22 |
| 04573596202227 | APERTO Lucent | MR-QFC-83N | Flexible Body coil N(L) MR-QFC-83N for APERTO Luce | 2026-05-22 |
| 04547410571134 | FDR AQRO | DR-XD 1000 MBL ES US E | | 2026-03-20 |
| 14547410566250 | FUJIFILM | DH-084STR | | 2026-02-27 |
| 14547410566298 | FUJIFILM | DH-094STR | | 2026-02-27 |
| 14547410566335 | FUJIFILM | DH-104STR | | 2026-02-27 |
| 14547410566373 | FUJIFILM | DH-114STR | | 2026-02-27 |
| 14547410566410 | FUJIFILM | DH-124STR | | 2026-02-27 |
Other Devices Sharing Product Codes
xxx.xxx