FDA UDI
In Commercial Distribution
🇺🇸 United States
GREENLIGHT
DI: 04055207018248
·
Model: 8632912
·
Richard Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- GREENLIGHT
- Primary DI
- 04055207018248
- Version / Model
- 8632912
- Catalog Number
- 8632.912
- Company Name
- Richard Wolf GmbH
- Labeler DUNS
- 315304071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 6
- Public Version Date
- 2024-11-21
- Public Version Status
- Update
- Public Device Record Key
- f0c19750-40a6-4339-8011-cf4f3e996360
Device Description
LASER WORKING INSERT 30 color code black, round, without pivot angle limitation, distal sheath end slanted, compatible with sheaths 8632027, 8655345, and telescopes Ø 4mm, 0°-30°, bayonet-cap, 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 |
|---|---|---|---|---|
| FBO | CYSTOURETHROSCOPE | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37085 | Rigid endoscope working guide | An endoscopic device that is a component of a rigid endoscope assembly that is used to assist the entry of a rigid endotherapy electrode into an appropriate rigid endoscope. It can provide either an active or passive activation of the electrode's cutting path. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04055207018248 | GS1 |
Customer Contacts
- Phone
- +497043350
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Angle | 30 | degree |