FDA UDI
In Commercial Distribution
🇺🇸 United States
SMART
DI: 00821925033740
·
Model: 70131013
·
Gyrus Acmi, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SMART
- Primary DI
- 00821925033740
- Version / Model
- 70131013
- Company Name
- Gyrus Acmi, Inc.
- Labeler DUNS
- 007198742
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 4
- Public Version Date
- 2023-08-16
- Public Version Status
- Update
- Public Device Record Key
- 7be07743-736e-4a24-8c3e-81f414730850
Device Description
SMART THERMAL TIP WITH DRAPE
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 |
|---|---|---|---|---|
| ETB | Prosthesis, Partial Ossicular Replacement | Ear, Nose, Throat | 874.3450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35029 | Electrocautery system generator, battery-powered | A battery-powered device that produces and delivers a regulated electrical current used to heat the electrode tip or wire loop of a cutting instrument used during surgical intervention to burn or sear body tissue. It is used to stop bleeding (cauterization of blood vessels), to treat superficial skin lesions, e.g., the removal of warts, the removal of gastrointestinal polyps via an appropriate endoscope, or to occlude fallopian tubes during sterilization procedures. It will typically contain electronic circuits and have a built-in thermocoupler to help control the temperature at the electrode. This is not an electrosurgical diathermy system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00821925024236 | GS1 | 6 | In Commercial Distribution | ||
| Primary | 00821925033740 | GS1 |
Customer Contacts
- Phone
- 1(800)262-3540
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K003214 | 000 |