FDA UDI In Commercial Distribution 🇺🇸 United States

BOND

DI: 09349458005634 · Model: Printer Ribbon & Labels for Cognitive Cxi (6 Pack) · LEICA BIOSYSTEMS MELBOURNE PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
BOND
Primary DI
09349458005634
Version / Model
Printer Ribbon & Labels for Cognitive Cxi (6 Pack)
Catalog Number
S21.4604
Company Name
LEICA BIOSYSTEMS MELBOURNE PTY LTD
Labeler DUNS
753184944
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-08-02
Public Version
1
Public Version Date
2024-08-12
Public Version Status
New
Public Device Record Key
a018f404-9544-412c-b30d-41654659993f

Device Description

Used with the slide labeller to print stick on labels to attach to slides. The slides are used on the BOND instrument.

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
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KPA Slide Stainer, Automated

GMDN Terms

Code Name
15599 Microscope slide stainer IVD

Identifiers

Type ID
Primary 09349458005634