FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SonoSurg Curved Scissors,HF,Inline Grip,5mm x 19cm
DI: 04953170235702
·
Model: T3925
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SonoSurg Curved Scissors,HF,Inline Grip,5mm x 19cm
- Primary DI
- 04953170235702
- Version / Model
- T3925
- Company Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Labeler DUNS
- 711789789
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-06
- Public Version
- 8
- Public Version Date
- 2023-01-16
- Public Version Status
- Update
- Public Device Record Key
- bda9df18-1240-413b-b910-aba8176dd1a3
- Distribution End Date
- 2022-08-15
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
- Yes
- 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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LFL | Instrument, ultrasonic surgical | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64417 | Soft-tissue ultrasonic surgical system holder/tip, reusable | A hand-held component of an ultrasonic surgical system which includes a holder with controls and a surgical endpiece (tip) intended to be connected to a system transducer (not included) whereby the tip oscillates (vibrates) at high frequency in order to fragment soft-tissue cells for cutting and/or coagulating soft tissue during surgery. It may be referred to as a handpiece but does not include a transducer; the tip is available in a variety of forms and sizes, is typically made of metal, and may include a disposable tube to cover the shaft of the tip. This device is utilized in a variety of surgical disciplines. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14953170235709 | GS1 | 1 | Not in Commercial Distribution | 2022-08-15 | |
| Primary | 04953170235702 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]