FDA UDI
In Commercial Distribution
🇺🇸 United States
THUNDERBEAT 5 mm, 35 cm, Pistol Grip
DI: 04953170308659
·
Model: TB-0535PC
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- THUNDERBEAT 5 mm, 35 cm, Pistol Grip
- Primary DI
- 04953170308659
- Version / Model
- TB-0535PC
- Company Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Labeler DUNS
- 711789789
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 5
- Public Version Date
- 2023-01-16
- Public Version Status
- Update
- Public Device Record Key
- 607e833c-cca4-4bb6-b148-d4fcecd08783
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
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | General, Plastic Surgery | 878.4400 | 2 |
| KNS | Unit, electrosurgical, endoscopic (with or without accessories) | Gastroenterology, Urology | 876.4300 | 2 |
| LFL | Instrument, ultrasonic surgical | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64246 | Endoscopic electrosurgical/ultrasonic surgical system instrument | A hand-held, endoscopic device intended to be used as part of an electrosurgical/ultrasonic system to deliver both: 1) ultrasonic energy; and 2) bipolar electrosurgical current for fragmenting, cutting and coagulation of soft-tissues during endoscopic (e.g., laparoscopic) surgery; it may in addition be intended for open surgery. It includes a handpiece/holder with controls and a long, thin shaft with distal electrodes and an ultrasonic tip, and may include a lumen for suction/irrigation; it does not include an ultrasonic transducer. It is available in a variety of forms (e.g., forceps, rigid probe). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14953170308656 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 04953170308659 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]