FDA UDI
In Commercial Distribution
🇺🇸 United States
E-LINE
DI: 04055207010884
·
Model: 865416
·
Richard Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- E-LINE
- Primary DI
- 04055207010884
- Version / Model
- 865416
- Catalog Number
- 8654.16
- Company Name
- Richard Wolf GmbH
- Labeler DUNS
- 315304071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-26
- Public Version
- 7
- Public Version Date
- 2024-12-02
- Public Version Status
- Update
- Public Device Record Key
- 53528bc1-e526-4f54-b877-d5616c32249d
Device Description
OBTURATOR RESECTOSCOPE 22FR color code green, WL 230 mm, round, rounded distal end, compatible with E-Line sheaths 8654.064, 8663.064, 8655.344, 8655.144, 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
- No
- 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
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FJL | RESECTOSCOPE | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35692 | Rigid endoscope obturator | An endoscopic device that is a component of a rigid endoscope assembly that has a distally rounded, solid, head or end that is placed into the sheath of a rigid endoscope in order to fill out the sheath's lumen (open end), thereby assisting its insertion into the body and protecting against damage to the patient. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04055207010884 | GS1 |
Customer Contacts
- Phone
- +497043350
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 7.33333333333 | Millimeter |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius