FDA UDI In Commercial Distribution 🇺🇸 United States

PRO3DURE GR-18.1 IB

DI: EPRCD1001462 · Model: 1 kg bottle ; clear-transparent · pro3dure medical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
PRO3DURE GR-18.1 IB
Primary DI
EPRCD1001462
Version / Model
1 kg bottle ; clear-transparent
Catalog Number
D1001462
Company Name
pro3dure medical GmbH
Labeler DUNS
312947842
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-09-12
Public Version
1
Public Version Date
2022-09-20
Public Version Status
New
Public Device Record Key
1070eca4-1d5a-49d6-9664-4c957d3c66b2

Device Description

1 kg bottle ; clear-transparent

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
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EBH Material, Impression Tray, Resin

GMDN Terms

Code Name
34808 Dental base plate

Identifiers

Type ID
Primary EPRCD1001462