FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 10886982007407
·
Model: SD516.324
·
SYNTHES (U.S.A.) LP
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 10886982007407
- Version / Model
- SD516.324
- Catalog Number
- SD516324
- Company Name
- SYNTHES (U.S.A.) LP
- Labeler DUNS
- 832637081
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-31
- Public Version
- 5
- Public Version Date
- 2018-12-03
- Public Version Status
- Update
- Public Device Record Key
- 525994e3-2e0d-4d06-8ca5-1cabbf079a29
- Distribution End Date
- 2018-12-01
Device Description
EX NAIL POWER ADAPTER
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44641 | Multi-purpose surgical power tool system, rechargeable battery-powered | An assembly of devices designed to resect bones and tough tissues (e.g., cartilage, ligaments) during a surgical procedure; it is not dedicated to a specific clinical application. It includes a rechargeable battery pack/control unit which supplies low-voltage electricity, motors/handpieces/power tool attachments, and a variety of tools (e.g., drill bits, burs, saw blades, screwdriver bits, and guide wires); it is not intended to be connected to mains power. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | H679SD5163240 | HIBCC | ||||
| Primary | 10886982007407 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]