FDA UDI
In Commercial Distribution
🇺🇸 United States
FUJIFILM
DI: 04547410074093
·
Model: DH-17EN
·
FUJIFILM CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- FUJIFILM
- Primary DI
- 04547410074093
- Version / Model
- DH-17EN
- Company Name
- FUJIFILM CORPORATION
- Labeler DUNS
- 713565195
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 5
- Public Version Date
- 2024-06-07
- Public Version Status
- Update
- Public Device Record Key
- c52ab8e4-3951-47e3-8e54-137c4147702d
Device Description
This product is the hood for observation assistance used in combination with our endoscopes in medical facilities.
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- High-level Disinfectant, Moist Heat or Steam Sterilization, Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FDF | Colonoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
| FDA | Enteroscope and accessories | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58841 | Endoscope tissue removal cap, single-use | A plastic tube designed to be placed onto the distal end of an endoscope (e.g., oesophagoscope) to facilitate the removal of coagulated blood/tissue from the path of the endoscope during endoscopic surgery. It is designed to fit tightly without fixing, having an oblique leading edge that extends beyond the end of the endoscope to provide atraumatic penetration and tissue removal functionality (e.g., scooping, grasping). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04547410074093 | GS1 | ||||
| Unit of Use | 84547410074099 | GS1 |
Customer Contacts
- Phone
- +018002728465
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143556 | 000 |