FDA UDI In Commercial Distribution 🇺🇸 United States

Ring probe 45 degrees, 26 x 32 mm

DI: 00816389021945 · Model: GM11001230 · Varian Medical Systems Deutschland GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Ring probe 45 degrees, 26 x 32 mm
Primary DI
00816389021945
Version / Model
GM11001230
Catalog Number
GM11001230
Company Name
Varian Medical Systems Deutschland GmbH
Labeler DUNS
332474605
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-22
Public Version
3
Public Version Date
2018-07-06
Public Version Status
Update
Public Device Record Key
0e3d8cb8-0893-4603-94f5-5e7e7a7b954b

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
MR Conditional
Direct Marking Exempt
No
PM Exempt
No
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
JAQ System, applicator, radionuclide, remote-controlled

GMDN Terms

Code Name
38409 Cervical/intrauterine brachytherapy system applicator, remote-afterloading

Identifiers

Type ID
Primary 00816389021945

Premarket Submissions

Submission Number Supplement Number
K150839 000

Device Sizes

Type Value Unit Text
Angle 45 degree