FDA UDI
In Commercial Distribution
🇺🇸 United States
E-LINE
DI: 04055207019016
·
Model: 8655996
·
Richard Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
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Basic Information
- Brand Name
- E-LINE
- Primary DI
- 04055207019016
- Version / Model
- 8655996
- Catalog Number
- 8655.996
- Company Name
- Richard Wolf GmbH
- Labeler DUNS
- 315304071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 8
- Public Version Date
- 2024-11-21
- Public Version Status
- Update
- Public Device Record Key
- d0aad9a5-0615-49f1-960b-f2519c73f247
Device Description
SEAL Resectoscope, PACK=6 PCS, 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
- Yes
- 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 |
|---|---|---|---|---|
| FDC | RESECTOSCOPE, WORKING ELEMENT | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44806 | Surgical instrument seal/seal maintenance set | A seal/collection of seals (e.g., O-rings, shaped or viscous gaskets) intended to be used to replace a damaged sealing component in the maintenance of certain endoscopes, microscopes, injectors, or other surgical instruments. It may include supportive hand tools (screwdrivers). It is not a laparoscopic access cannula seal. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04055207019016 | GS1 | ||||
| Unit of Use | 04055207059418 | GS1 |
Customer Contacts
- Phone
- +497043350
- [email protected]