FDA UDI In Commercial Distribution 🇺🇸 United States

Medichoice

DI: 10885632101748 · Model: ORT06B · OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
6

Basic Information

Brand Name
Medichoice
Primary DI
10885632101748
Version / Model
ORT06B
Company Name
OWENS & MINOR DISTRIBUTION, INC.
Labeler DUNS
007941230
Distribution Status
In Commercial Distribution
Device Count in Pkg
6
Record Status
Published
Publish Date
2016-08-20
Public Version
3
Public Version Date
2018-07-06
Public Version Status
Update
Public Device Record Key
15d83ee3-09c5-40ad-b340-1526650fa4a4

Device Description

Towel Operating Room Pre-Washed De-Linted Cotton Blue 16 X 24 Inch Disposable 6 Pack Sterile Not Made With Natural Rubber Latex MediChoice

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

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
KKX Drape, surgical

GMDN Terms

Code Name
14077 Surgical towel

Identifiers

Type ID
Package 50885632101746
Primary 10885632101748
Unit of Use 60885632101743

Premarket Submissions

Submission Number Supplement Number
K001858 000

Storage Conditions

Type
Special Storage Condition, Specify
Special Conditions
Keep Dry
Type
Special Storage Condition, Specify