FDA UDI In Commercial Distribution 🇺🇸 United States

Laminated Bite Wafers-Wax

DI: D8453003102 · Model: 3003102 · Denplus Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Laminated Bite Wafers-Wax
Primary DI
D8453003102
Version / Model
3003102
Catalog Number
3003102
Company Name
Denplus Inc
Labeler DUNS
202016064
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-09-21
Public Version
1
Public Version Date
2021-09-29
Public Version Status
New
Public Device Record Key
473ec03c-830c-4699-b944-5c042eb08a2e

Device Description

Laminated Bite Wafers-Wax, White, 35 units

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
Yes
MRI Safety
MR Safe
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
No

Product Codes

Code Name
EGD Wax, Dental, Intraoral

GMDN Terms

Code Name
38602 Bite registration rim wax

Identifiers

Type ID
Primary D8453003102