FDA UDI In Commercial Distribution 🇺🇸 United States

SABER-C BASE WITH INSERT TRAY

DI: 00810017913497 · Model: CI-TRAY2-SABERC · ELEVATION SPINE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
SABER-C BASE WITH INSERT TRAY
Primary DI
00810017913497
Version / Model
CI-TRAY2-SABERC
Catalog Number
CI-TRAY2-SABERC
Company Name
ELEVATION SPINE, INC.
Labeler DUNS
085718404
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-01-19
Public Version
1
Public Version Date
2024-01-29
Public Version Status
New
Public Device Record Key
5a22b350-2182-4ac8-a5be-1fc1ef3e24fe

Device Description

SABER-C BASE WITH INSERT TRAY

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
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
Moist Heat or Steam Sterilization

Product Codes

Code Name
LRP Tray, Surgical

GMDN Terms

Code Name
12143 Instrument tray, reusable

Identifiers

Type ID
Primary 00810017913497