FDA UDI In Commercial Distribution 🇺🇸 United States

pinky wood wedges

DI: E2995011PLUS0 · Model: 5011PLUS · Polydentia SA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1000

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Basic Information

Brand Name
pinky wood wedges
Primary DI
E2995011PLUS0
Version / Model
5011PLUS
Catalog Number
5011PLUS
Company Name
Polydentia SA
Labeler DUNS
481461598
Distribution Status
In Commercial Distribution
Device Count in Pkg
1000
Record Status
Published
Publish Date
2023-08-23
Public Version
2
Public Version Date
2024-02-05
Public Version Status
Update
Public Device Record Key
ebc1c56f-e752-4e5e-97e9-6d6ddfedef57

Device Description

11mm (XS) 1000 pcs.

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DZN Instruments, Dental Hand

GMDN Terms

Code Name
45007 Dental wedge, single-use

Identifiers

Type ID
Unit of Use E2995011PLUS9
Primary E2995011PLUS0