FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 04055207009840
·
Model: 838366
·
Richard Wolf GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 04055207009840
- Version / Model
- 838366
- Catalog Number
- 8383.66
- Company Name
- Richard Wolf GmbH
- Labeler DUNS
- 315304071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-19
- Public Version
- 3
- Public Version Date
- 2025-01-13
- Public Version Status
- Update
- Public Device Record Key
- 19b1c938-534b-4caa-9282-fe985880e0eb
Device Description
PROBE Ø 5MM WL 328MM graduated, 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
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FGM | PROBE AND DIRECTOR, GASTRO-UROLOGY | Gastroenterology, Urology | 876.4730 | 1 |
| NWV | Laparoscopic accessories, gynecologic | Obstetrics/Gynecology | 884.1720 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35948 | Endoscopic surgical probe | A slender, rod-like, hand-held manual surgical instrument intended to be inserted through an endoscope (e.g., arthroscope, laparoscope) to explore, measure, and/or perform therapeutic procedures during various types of surgical interventions (excludes cryosurgery). It is made of metallic and/or synthetic polymer material. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04055207009840 | GS1 |
Customer Contacts
- Phone
- +497043350
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity