FDA UDI In Commercial Distribution 🇺🇸 United States

NitriDerm® COATS™

DI: 20813172020646 · Model: 125202 · INNOVATIVE HEALTHCARE CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
200

Basic Information

Brand Name
NitriDerm® COATS™
Primary DI
20813172020646
Version / Model
125202
Company Name
INNOVATIVE HEALTHCARE CORPORATION
Labeler DUNS
802020693
Distribution Status
In Commercial Distribution
Device Count in Pkg
200
Record Status
Published
Publish Date
2022-12-08
Public Version
1
Public Version Date
2022-12-16
Public Version Status
New
Public Device Record Key
a92f0f25-b31b-4862-895a-9dbf3cb55f4e

Device Description

Gloves, Exam, Nitrile, Non-Sterile, Powder-Free, Colloidal Oatmeal, Therapeutic, M

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
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
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
LZA Polymer Patient Examination Glove
LZC Patient Examination Glove, Specialty

GMDN Terms

Code Name
56286 Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Identifiers

Type ID
Package 10813172020649
Primary 20813172020646
Unit of Use 00813172020642