FDA UDI
In Commercial Distribution
🇺🇸 United States
AESCULAP
DI: 04046955057443
·
Model: MG624
·
AESCULAP, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AESCULAP
- Primary DI
- 04046955057443
- Version / Model
- MG624
- Catalog Number
- MG624
- Company Name
- AESCULAP, INC.
- Labeler DUNS
- 082594540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-27
- Public Version
- 3
- Public Version Date
- 2021-04-27
- Public Version Status
- Update
- Public Device Record Key
- 2e202987-d7d5-4f94-b230-27769f0ac47e
Device Description
PROBE W/EYE D1.65MM 305MM SILVER
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46486 | Gastro-urological director | A slender, rod-like surgical instrument made of metal, typically with groove running along the centre of it distal shaft and/or continuing with an elongated malleable wire loop, that is used to guide other devices or instruments into a selected intracorporeal location during a gastroenterological/urological (GU) procedure. The distal shaft may be straight or curved and the proximal handle formed as a finger grip. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046955057443 | GS1 |
Customer Contacts
- Phone
- +1(800)282-9000
- [email protected]