FDA UDI
In Commercial Distribution
🇺🇸 United States
FMwand
DI: 00859729006103
·
Model: 2101S
·
DOMAIN SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- FMwand
- Primary DI
- 00859729006103
- Version / Model
- 2101S
- Catalog Number
- FM2101S
- Company Name
- DOMAIN SURGICAL, INC.
- Labeler DUNS
- 963249342
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-10
- Public Version
- 4
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- 313cc2b0-a428-4b4c-b076-4259d4df8595
Device Description
FMwand Handpiece with Integrated Smoke Evacuation - 100 mm Length with 2 mm Dissecting Loop
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
- Yes
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| 44681 | Electrosurgical handpiece, single-use | A hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to a generator; it is not intended for use during inert gas-enhanced electrosurgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20859729006107 | GS1 | Box | 5 | In Commercial Distribution | |
| Package | 10859729006100 | GS1 | Sterile Pouch | 1 | In Commercial Distribution | |
| Primary | 00859729006103 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140384 | 000 |