FDA UDI In Commercial Distribution 🇺🇸 United States

Sunshine Diamonds

DI: ESUNG30450MM8 · Model: G304-50MM · Dr. Hopf GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10

Basic Information

Brand Name
Sunshine Diamonds
Primary DI
ESUNG30450MM8
Version / Model
G304-50MM
Company Name
Dr. Hopf GmbH & Co. KG
Labeler DUNS
322126798
Distribution Status
In Commercial Distribution
Device Count in Pkg
10
Record Status
Published
Publish Date
2023-06-30
Public Version
1
Public Version Date
2023-07-10
Public Version Status
New
Public Device Record Key
db05f5c3-fb67-405a-beb9-471c11ed4d6c

Device Description

Separating strips

Device Characteristics

Single Use
Yes
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
Yes
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
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
EHM Strip, Polishing Agent

GMDN Terms

Code Name
35702 Dental abrasive strip, single-use

Identifiers

Type ID
Unit of Use ESUNG30450MM1
Primary ESUNG30450MM8