FDA UDI In Commercial Distribution 🇺🇸 United States

PROOF

DI: D832800221 · Model: 8002-2 · PLASDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100

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Basic Information

Brand Name
PROOF
Primary DI
D832800221
Version / Model
8002-2
Catalog Number
8002-2
Company Name
PLASDENT CORPORATION
Labeler DUNS
190377184
Distribution Status
In Commercial Distribution
Device Count in Pkg
100
Record Status
Published
Publish Date
2022-03-25
Public Version
1
Public Version Date
2022-04-04
Public Version Status
New
Public Device Record Key
57a53709-91a9-4774-b8d9-98dd5cafa65d

Device Description

Tie-On Surgeon's Cap, Blue

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
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
NRD Unit, Operative Dental, Accessories

GMDN Terms

Code Name
32297 Surgical cap, single-use

Identifiers

Type ID
Package D832800222
Primary D832800221
Unit of Use D832800220