FDA UDI In Commercial Distribution 🇺🇸 United States

ET RIGID PROTECT CAP

DI: 00810019240201 · Model: ETRPC6007S · HIOSSEN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ET RIGID PROTECT CAP
Primary DI
00810019240201
Version / Model
ETRPC6007S
Company Name
HIOSSEN, INC.
Labeler DUNS
796083090
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-05-15
Public Version
1
Public Version Date
2019-05-23
Public Version Status
New
Public Device Record Key
8d209bb4-32ee-45d6-a5b1-4376261e6a42

Device Characteristics

Single Use
Yes
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
No
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
NDP Accessories, Implant, Dental, Endosseous

GMDN Terms

Code Name
44880 Dental implant suprastructure, temporary, preformed, single-use

Identifiers

Type ID
Primary 00810019240201

Premarket Submissions

Submission Number Supplement Number
K161689 000