FDA UDI In Commercial Distribution 🇺🇸 United States

UNBRANDED

DI: 00848340000348 · Model: 01-4040 · ADVANCE MEDICAL DESIGNS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
UNBRANDED
Primary DI
00848340000348
Version / Model
01-4040
Company Name
ADVANCE MEDICAL DESIGNS, INC.
Labeler DUNS
130785884
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-23
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
d6073433-3c15-4877-a725-62ad005e1aa0

Device Description

Snap Kover

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
Yes
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
Yes
Sterilization Methods
Ethylene Oxide

Product Codes

Code Name
JAA System, x-ray, fluoroscopic, image-intensified

GMDN Terms

Code Name
45021 Instrument/equipment drape, single-use, sterile

Identifiers

Type ID
Package 10848340000345
Primary 00848340000348