FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 04055207009550
·
Model: 827055
·
Richard Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 04055207009550
- Version / Model
- 827055
- Catalog Number
- 8270.55
- Company Name
- Richard Wolf GmbH
- Labeler DUNS
- 315304071
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-26
- Public Version
- 4
- Public Version Date
- 2023-11-17
- Public Version Status
- Update
- Public Device Record Key
- b7984f01-8d29-4193-bf7a-5df7d174a6d6
- Distribution End Date
- 2023-04-13
Device Description
ESOPHAGOSCOPE-TUBE ID 6.3MM OD 7.5mm, TL 300mm, with proximal light connection, reusable
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Hydrogen Peroxide", "Ethylene Oxide", "Moist Heat or Steam Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EOX | ESOPHAGOSCOPE (FLEXIBLE OR RIGID) | Ear, Nose, Throat | 874.4710 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36653 | Rigid optical oesophagoscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the oesophagus. It is inserted into the body through the mouth. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine abnormalities in the tissue structure and mucous lining of the oesophagus. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04055207009550 | GS1 |
Customer Contacts
- Phone
- +497043350
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 6.3 | Millimeter |