FDA UDI
In Commercial Distribution
🇺🇸 United States
ProDriver Battery Pack, Single
DI: 00860540000256
·
Model: PDBP-001-2
·
PRO-DEX, INC.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ProDriver Battery Pack, Single
- Primary DI
- 00860540000256
- Version / Model
- PDBP-001-2
- Company Name
- PRO-DEX, INC.
- Labeler DUNS
- 849370358
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-29
- Public Version
- 4
- Public Version Date
- 2024-02-08
- Public Version Status
- Update
- Public Device Record Key
- 653c2ad4-fb9e-4b3c-87f0-63aae184d4d1
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GXL | Screwdriver, Skullplate | Neurology | 882.4900 | 1 |
| GEY | Motor, Surgical Instrument, Ac-Powered | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48058 | Disposable battery pack | A group of battery cells (e.g., lithium ion cells) held within a container that is sterile used to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet. This device is typically designed to power cordless surgical power tools (e.g., a non-rechargeable battery-powered surgical drilling system handpiece) and is non-rechargeable. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860540000256 | GS1 | ||||
| Package | 00860540000270 | GS1 | Case | 40 | In Commercial Distribution | |
| Package | 00860540000263 | GS1 | 10 | In Commercial Distribution |