FDA UDI In Commercial Distribution 🇺🇸 United States

SM DRYFIELD KIT RED *I

DI: D7753004000 · Model: 300-400 · Great Lakes Dental Technologies, Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
SM DRYFIELD KIT RED *I
Primary DI
D7753004000
Version / Model
300-400
Catalog Number
300-400
Company Name
Great Lakes Dental Technologies, Ltd.
Labeler DUNS
041854332
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-05-18
Public Version
4
Public Version Date
2021-02-02
Public Version Status
Update
Public Device Record Key
a05596e2-5d74-4bbe-81b3-655f6b90f1e9

Device Description

SM DRYFIELD KIT RED *I

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
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
DYN Mouthpiece, Saliva Ejector

GMDN Terms

Code Name
44828 Dental cheek retractor, professional, reusable

Identifiers

Type ID
Primary D7753004000

Customer Contacts

Phone
800-828-7626