FDA UDI
In Commercial Distribution
🇺🇸 United States
AESCULAP
DI: 04046955281374
·
Model: US416SU
·
AESCULAP, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- AESCULAP
- Primary DI
- 04046955281374
- Version / Model
- US416SU
- Catalog Number
- US416SU
- Company Name
- AESCULAP, INC.
- Labeler DUNS
- 082594540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2020-08-10
- Public Version
- 1
- Public Version Date
- 2020-08-18
- Public Version Status
- New
- Public Device Record Key
- 7a1b8c1e-4015-4579-9862-61634ebb361a
Device Description
GOLDTIP IRRIG DISPO FCPS 190MM 1.5MM
Device Characteristics
- Single Use
- Yes
- 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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | Electrosurgical, cutting & coagulation & accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56296 | Open-surgery electrosurgical handpiece/electrode, bipolar, single-use | A sterile rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 04046955281367 | GS1 | ||||
| Primary | 04046955281374 | GS1 |
Customer Contacts
- Phone
- +1(800)282-9000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K900533 | 000 |