FDA UDI In Commercial Distribution 🇺🇸 United States

ACCUFIT

DI: 10884389029510 · Model: SHR310 · MEDLINE INDUSTRIES, INC.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
ACCUFIT
Primary DI
10884389029510
Version / Model
SHR310
Catalog Number
SHR310
Company Name
MEDLINE INDUSTRIES, INC.
Labeler DUNS
025460908
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-01-26
Public Version
1
Public Version Date
2021-02-03
Public Version Status
New
Public Device Record Key
f0ff81bb-2a51-48fb-b3ff-d51d20c1f9a3

Device Description

ACCUFIT SENTINELLE HEADREST COVER-LARGE

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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
No
Sterilization Prior Use
No

Product Codes

Code Name
PUI Drape, surgical, exempt
KKX Drape, surgical
MMP Cover, barrier, protective

GMDN Terms

Code Name
12535 Medical equipment drape, single-use

Identifiers

Type ID
Package 40884389029511
Primary 10884389029510

Customer Contacts