FDA UDI In Commercial Distribution 🇺🇸 United States

Polarcup Instrument Tray Inner

DI: 09421028114837 · Model: 35130081 · ENZTEC LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Polarcup Instrument Tray Inner
Primary DI
09421028114837
Version / Model
35130081
Catalog Number
35130081
Company Name
ENZTEC LIMITED
Labeler DUNS
592616445
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-02-17
Public Version
1
Public Version Date
2023-02-27
Public Version Status
New
Public Device Record Key
71b20dc9-d091-46b1-8607-4a2149470e73

Device Description

Tray/case used to hold other medical devices

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
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 09421028114837