FDA UDI Not in Commercial Distribution 🇺🇸 United States

THUNDERBEAT Open Fine Jaw Type X

DI: 04953170394577 · Model: TB-0009OFX · OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
THUNDERBEAT Open Fine Jaw Type X
Primary DI
04953170394577
Version / Model
TB-0009OFX
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
2020-07-08
Public Version
4
Public Version Date
2022-08-29
Public Version Status
Update
Public Device Record Key
4d4f8e62-d96b-4f40-a879-3b6514bb39b6
Distribution End Date
2022-02-21

Device Description

THUNDERBEAT Open Fine Jaw Type X

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
GEI Electrosurgical, cutting & coagulation & accessories
LFL Instrument, ultrasonic surgical

GMDN Terms

Code Name
64246 Endoscopic electrosurgical/ultrasonic surgical system instrument

Identifiers

Type ID
Package 14953170394574
Primary 04953170394577

Customer Contacts