FDA UDI In Commercial Distribution 🇺🇸 United States

NA

DI: 05032384005697 · Model: CT0024B · OXOID LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5

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Basic Information

Brand Name
NA
Primary DI
05032384005697
Version / Model
CT0024B
Company Name
OXOID LIMITED
Labeler DUNS
365355452
Distribution Status
In Commercial Distribution
Device Count in Pkg
5
Record Status
Published
Publish Date
2016-09-24
Public Version
3
Public Version Date
2018-07-06
Public Version Status
Update
Public Device Record Key
d5580b4e-fbf2-48c2-bc7d-b9ce84eb9f74

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
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
No
Sterilization Prior Use
No

Product Codes

Code Name
JTN Susceptibility Test Discs, Antimicrobial

GMDN Terms

Code Name
45529 Gentamicin susceptibility testing disc IVD

Identifiers

Type ID
Primary 05032384005697
Unit of Use 05032384502585

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K860153 000