FDA UDI
In Commercial Distribution
🇺🇸 United States
Greenwald Surgical Company, Inc.
DI: 10801334013790
·
Model: 33840-27
·
GRACE MANUFACTURING, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Greenwald Surgical Company, Inc.
- Primary DI
- 10801334013790
- Version / Model
- 33840-27
- Catalog Number
- U447BS
- Company Name
- GRACE MANUFACTURING, INC.
- Labeler DUNS
- 607903382
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2019-02-07
- Public Version Status
- Update
- Public Device Record Key
- 0b9ece8b-6e66-48a4-81d0-5cc54cf35df1
Device Description
Teflon insulation. Precision machined stainless steel and nickel/silver electrode tip. 3mm ball (small roller) electrode
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| FAS | Electrode, Electrosurgical, Active, Urological | Gastroenterology, Urology | 876.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61874 | Open-surgery electrosurgical electrode, monopolar, single-use | An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801334013721 | GS1 | Dispenser Box | 6 | In Commercial Distribution | |
| Primary | 10801334013790 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Sheath size:27 French |