FDA UDI In Commercial Distribution 🇺🇸 United States

Uni-Wedge Regular ( Orange)

DI: D248938521 · Model: 93852 · HAGER WORLDWIDE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
250

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Basic Information

Brand Name
Uni-Wedge Regular ( Orange)
Primary DI
D248938521
Version / Model
93852
Company Name
HAGER WORLDWIDE, INC.
Labeler DUNS
009277971
Distribution Status
In Commercial Distribution
Device Count in Pkg
250
Record Status
Published
Publish Date
2026-01-28
Public Version
1
Public Version Date
2026-02-05
Public Version Status
New
Public Device Record Key
4b1a06ed-f50f-4dae-884d-b0e6aac4c328

Device Description

Dental wedges

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
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EIF Accessories, Retractor, Dental

GMDN Terms

Code Name
45007 Dental wedge, single-use

Identifiers

Type ID
Unit of Use D248938520
Primary D248938521