FDA UDI In Commercial Distribution 🇺🇸 United States

Henry Schein

DI: 10304040119270 · Model: 5701659 · HENRY SCHEIN, INC.
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Henry Schein
Primary DI
10304040119270
Version / Model
5701659
Catalog Number
5701659
Company Name
HENRY SCHEIN, INC.
Labeler DUNS
012430880
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-02-05
Public Version
3
Public Version Date
2022-06-17
Public Version Status
Update
Public Device Record Key
2767c25b-75c0-4605-8fce-85ce55ec049d

Device Description

Ortho Lower Extremity Pack 6

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
Yes
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
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
Yes
Sterilization Methods
Ethylene Oxide

Product Codes

Code Name
LRO General surgery tray
OJH Orthopedic tray
OGR Ear, nose, and throat surgical tray
PPF Urinary irrigation kit
FDE laparoscopy kit

GMDN Terms

Code Name
33961 General surgical procedure kit, non-medicated, single-use

Identifiers

Type ID
Primary 10304040119270