FDA UDI
In Commercial Distribution
🇺🇸 United States
DIEGO ELITE
DI: 00821925038530
·
Model: MM4000SS
·
Gyrus Acmi, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DIEGO ELITE
- Primary DI
- 00821925038530
- Version / Model
- MM4000SS
- Company Name
- Gyrus Acmi, Inc.
- Labeler DUNS
- 007198742
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-14
- Public Version
- 4
- Public Version Date
- 2023-09-21
- Public Version Status
- Update
- Public Device Record Key
- d34e0758-1bac-470d-a430-62615f490231
Device Description
SHAVER BLADE, 4 MM, 40 DEGREES monopolar distal suction, T/A MALLEABLE, MONOPOLAR DIEGO ELITE
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 |
|---|---|---|---|---|
| 41589 | ENT shaver system | An assembly of mains electricity (AC-powered) devices designed to resect/debride soft and osseous (bone) tissue in the nasal cavity or ear region during ear/nose/throat (ENT) or plastic surgery procedures; including functional endoscopic sinus surgery (FESS). It typically consists of a power supply transformer/control unit with operational controls, setting display, electrical connecting cables, and a rotary handpiece(s) that can operate a variety of burs and blades (either straight or curved) or other rotary instruments. Some types may have dedicated software intended to provide optimal parameters for the procedure. An irrigation/suction system may be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00821925027978 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00821925038530 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123429 | 000 |