FDA UDI In Commercial Distribution 🇺🇸 United States

CERES-C

DI: 00840916138189 · Model: 08-170-0508 · SPINAL ELEMENTS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CERES-C
Primary DI
00840916138189
Version / Model
08-170-0508
Company Name
SPINAL ELEMENTS
Labeler DUNS
004022104
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-11-13
Public Version
3
Public Version Date
2022-03-10
Public Version Status
Update
Public Device Record Key
543ecd24-cb91-4cc8-b083-530e6882769e

Device Description

Ceres®-C Spacer 12X15X8, 5 deg

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
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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

GMDN Terms

Code Name
60762 Polymeric spinal interbody fusion cage

Identifiers

Type ID
Primary 00840916138189