FDA UDI
In Commercial Distribution
🇺🇸 United States
FUJIFILM
DI: 04547410433975
·
Model: EW10-VM01
·
FUJIFILM CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- FUJIFILM
- Primary DI
- 04547410433975
- Version / Model
- EW10-VM01
- Company Name
- FUJIFILM CORPORATION
- Labeler DUNS
- 713565195
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-23
- Public Version
- 2
- Public Version Date
- 2024-06-10
- Public Version Status
- Update
- Public Device Record Key
- 89ea6e4b-87d2-4198-b8cb-853ac4e8795d
Device Description
This software provides image information to assist the user in estimating the size of an object displayed in the endoscopic field of view. This software provides no therapeutic or diagnostic function.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FDF | Colonoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
| QTH | Endoscopic Light-Projecting Measuring Device | Gastroenterology, Urology | 876.1530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64793 | Endoscopic video image reference scale software | A software program intended to be used during endoscopy to superimpose a virtual reference scale on real-time endoscopic video images to assist the user in estimating the size of an object (e.g., lesion, polyp). It is used in conjunction with an endoscope capable of indicating a reference point for displaying the scale (e.g., via a laser beam), and interfaces with an endoscopic video image processing unit. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04547410433975 | GS1 |
Customer Contacts
- Phone
- +018002728465
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223827 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity