FDA UDI In Commercial Distribution 🇺🇸 United States

A Plus

DI: 00683534870044 · Model: 1 · A PLUS INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
A Plus
Primary DI
00683534870044
Version / Model
1
Catalog Number
SP-1000-6S
Company Name
A PLUS INTERNATIONAL INC.
Labeler DUNS
191705904
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-10-19
Public Version
1
Public Version Date
2022-10-27
Public Version Status
New
Public Device Record Key
396da33a-cc83-4898-93f9-b1c533701402

Device Description

A PLUS - Specialty Sponges , 1", Bleached White, Round Stick, X-Ray Detectable, Steam Pretreatment, 100 Pc(s)/Bag, 1000 Pc(s)/Case

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
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
Yes
Sterilization Methods
["Ethylene Oxide", "Moist Heat or Steam Sterilization", "Radiation Sterilization"]

Product Codes

Code Name
GDY Gauze/Sponge, Internal, X-Ray Detectable

GMDN Terms

Code Name
13698 Dissection sponge

Identifiers

Type ID
Package 80683534870040
Primary 00683534870044