FDA UDI In Commercial Distribution 🇺🇸 United States

PST Tray and Lid

DI: 00083208001901 · Model: PST 4.0x7.5x1.5 · Suncoast Dental, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PST Tray and Lid
Primary DI
00083208001901
Version / Model
PST 4.0x7.5x1.5
Catalog Number
PST 4711A
Company Name
Suncoast Dental, Inc
Labeler DUNS
078352849
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-12-07
Public Version
3
Public Version Date
2022-09-16
Public Version Status
Update
Public Device Record Key
4355430a-ddc3-4383-bcd3-3c35aaa33e6b

Device Description

Autoclavable cassette 4.0W x 7.5L x 1.5Deep: for instruments such as Sinus Flap retractors.

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
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 00083208001901

Customer Contacts

Phone
727-536-4880