FDA UDI In Commercial Distribution 🇺🇸 United States

Philips Zoom! IsoPrep Retractor

DI: 08710103632092 · Model: DIS574 · Discus Dental, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Philips Zoom! IsoPrep Retractor
Primary DI
08710103632092
Version / Model
DIS574
Catalog Number
881057401020
Company Name
Discus Dental, LLC
Labeler DUNS
831726109
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-08-28
Public Version
6
Public Version Date
2025-06-16
Public Version Status
Update
Public Device Record Key
5091add2-867f-499c-8ded-02dad1e62546

Device Description

Zoom! IsoPrep Retractor (Sm)

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
63315 Dental cheek retractor, professional, single-use

Identifiers

Type ID
Primary 08710103632092