FDA UDI
In Commercial Distribution
🇺🇸 United States
Plat Tip Adapter – Small
DI: 00810131881368
·
Model: RED-NTA-09
·
SURGENTEC, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Plat Tip Adapter – Small
- Primary DI
- 00810131881368
- Version / Model
- RED-NTA-09
- Company Name
- SURGENTEC, LLC
- Labeler DUNS
- 004095409
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-10
- Public Version
- 1
- Public Version Date
- 2025-06-18
- Public Version Status
- New
- Public Device Record Key
- 5a442aa8-f5c6-4ce8-89fc-41ef54246b2f
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| FMF | Syringe, Piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64343 | Orthopaedic cement ultrasonic surgical system handpiece tip, reusable | A removable endpiece intended to be attached to an ultrasonic surgical system handpiece to amplify and deliver ultrasonic energy to mechanically fragment and cut orthopaedic cement upon contact during an orthopaedic surgical procedure (e.g., revision hip arthroplasty); it is not intended to cut body tissues. It is available in a variety of sizes and forms (e.g., blade, rasp), and is not intended to be held directly; a channel for cement debris aspiration and a covering sleeve for delivery of irrigation solution may be included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810131881368 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243580 | 000 |