FDA UDI Not in Commercial Distribution 🇺🇸 United States

C-QUR MOSAIC

DI: 00650862311068 · Model: 31106 · Atrium Medical Corporation
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
C-QUR MOSAIC
Primary DI
00650862311068
Version / Model
31106
Company Name
Atrium Medical Corporation
Labeler DUNS
051798999
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2015-09-24
Public Version
7
Public Version Date
2022-06-10
Public Version Status
Update
Public Device Record Key
54698eac-9943-4be1-9a97-e8a5639f44d5
Distribution End Date
2019-12-31

Device Description

C-QUR Mosaic, 5.12in (13 cm) Round

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
MR Safe
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
OXA Mesh, surgical, non-absorbable, thoracic, chest wall reconstruction
FTL Mesh, surgical, polymeric

GMDN Terms

Code Name
44756 Extra-gynaecological surgical mesh, composite-polymer

Identifiers

Type ID
Primary 00650862311068

Premarket Submissions

Submission Number Supplement Number
K121070 000
K151386 000