FDA UDI In Commercial Distribution 🇺🇸 United States

Henry Schein

DI: 10304040141981 · Model: 5702401 · HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10

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Basic Information

Brand Name
Henry Schein
Primary DI
10304040141981
Version / Model
5702401
Catalog Number
5702401
Company Name
HENRY SCHEIN, INC.
Labeler DUNS
012430880
Distribution Status
In Commercial Distribution
Device Count in Pkg
10
Record Status
Published
Publish Date
2021-11-30
Public Version
1
Public Version Date
2021-12-08
Public Version Status
New
Public Device Record Key
70cd9e15-1382-4676-ab79-d8a9d9da2832

Device Description

Isolation Gown SMS Level 1 XL

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
OEA Non-surgical isolation gown

GMDN Terms

Code Name
35492 Isolation gown, single-use

Identifiers

Type ID
Unit of Use 00304040141984
Primary 10304040141981