FDA UDI In Commercial Distribution 🇺🇸 United States

Titanium Intrauterine tandems, angle 15 degrees

DI: 00816389020863 · Model: AL07522000 · Varian Medical Systems Deutschland GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Titanium Intrauterine tandems, angle 15 degrees
Primary DI
00816389020863
Version / Model
AL07522000
Catalog Number
AL07522000
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
2016-09-19
Public Version
3
Public Version Date
2018-07-06
Public Version Status
Update
Public Device Record Key
47ec5d32-05d9-4f3d-84a5-8c4476ce6ef6

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
38407 Vaginal brachytherapy system applicator, remote-afterloading

Identifiers

Type ID
Primary 00816389020863

Premarket Submissions

Submission Number Supplement Number
K952913 000

Device Sizes

Type Value Unit Text
Angle 15 degree