FDA UDI
In Commercial Distribution
🇺🇸 United States
ZAGUAR
DI: 08800038037014
·
Model: BH301
·
IMEDICOM CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ZAGUAR
- Primary DI
- 08800038037014
- Version / Model
- BH301
- Company Name
- IMEDICOM CO., LTD.
- Labeler DUNS
- 690340653
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-29
- Public Version
- 1
- Public Version Date
- 2020-06-08
- Public Version Status
- New
- Public Device Record Key
- 9cc1fe37-dae2-49d3-90a0-67c3fbb3a8dc
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEY | Motor, Surgical Instrument, Ac-Powered | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37867 | Surgical power tool system handpiece, rotary, rechargeable battery-powered | A hand-held device intended to provide rotation for a rotary endpiece instrument during surgical procedures performed on bones and tough tissues (e.g., cartilage, ligaments). It typically has the capacity to be used with a variety of rotary instruments (e.g., drill bits, reamers, cutters) and is not dedicated to a specific clinical procedure. It includes a built-in motor and an attachment for direct connection of an endpiece(s) [which is not included]. It is powered by an attached rechargeable battery pack to directly provide low-voltage electricity to the motor of the handpiece. The device may be cannulated to allow the use of a guidewire. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800038037014 | GS1 |