FDA UDI In Commercial Distribution 🇺🇸 United States

Paul Banditt

DI: D955LUXCASS1 · Model: LUX CASS · Terlain Enterprises, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Paul Banditt
Primary DI
D955LUXCASS1
Version / Model
LUX CASS
Company Name
Terlain Enterprises, Inc.
Labeler DUNS
177465051
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-12-11
Public Version
1
Public Version Date
2023-12-19
Public Version Status
New
Public Device Record Key
1a0097ab-c075-41ad-88c5-b501ce85a80f

Device Description

PAUL BANDITT AUTOCLAVE CASSETTE FOR TAPPING LUXATOR KIT, 7 INST., (177,5x84,5x33,0mm)

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
No
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
FSM Tray, Surgical, Instrument

GMDN Terms

Code Name
12143 Instrument tray, reusable

Identifiers

Type ID
Primary D955LUXCASS1