FDA UDI
In Commercial Distribution
🇺🇸 United States
Diego Elite
DI: 00821925035607
·
Model: MDHP200
·
Gyrus ACMI, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Diego Elite
- Primary DI
- 00821925035607
- Version / Model
- MDHP200
- Company Name
- Gyrus ACMI, LLC
- Labeler DUNS
- 007198742
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-16
- Public Version
- 4
- Public Version Date
- 2024-09-02
- Public Version Status
- Update
- Public Device Record Key
- 63d113e9-6938-41a3-aa42-68e8ed711c5f
Device Description
DRILL HANDPIECE BASE Diego Elite Drill
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ERL | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE | Ear, Nose, Throat | 874.4250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36865 | Arthroscopic shaver system handpiece, pneumatic | A handle with attached cutting blade that is a component of a pneumatically-powered shaver system designed for soft and bone tissue resection during arthroscopic surgery on a joint, e.g., a knee, shoulder, or ankle. It is typically connected to and regulated by a dedicated control unit. It may facilitate additional functions of the system (e.g., irrigation/suction) and is used in combination with appropriate endoscopic devices. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00821925035607 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152744 | 000 |