FDA UDI In Commercial Distribution 🇺🇸 United States

CarboJet XF® Bone Preparation System

DI: 00818720013145 · Model: 27-200-2000 · Kinamed, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CarboJet XF® Bone Preparation System
Primary DI
00818720013145
Version / Model
27-200-2000
Catalog Number
27-200-2000
Company Name
Kinamed, Inc.
Labeler DUNS
184896645
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-07-10
Public Version
1
Public Version Date
2023-07-18
Public Version Status
New
Public Device Record Key
3921fbec-0656-493f-bd2e-097c848ac9e6

Device Description

Handpiece Set with Femoral Canal Nozzle

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
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
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
FQH Lavage, Jet

GMDN Terms

Code Name
44052 Orthopaedic surgical procedure kit, non-medicated, single-use

Identifiers

Type ID
Primary 00818720013145