FDA UDI In Commercial Distribution 🇺🇸 United States

PEAK MEDICAL

DI: G453CFK100A0 · Model: CFK-100-A · Peak Medical Distribution Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PEAK MEDICAL
Primary DI
G453CFK100A0
Version / Model
CFK-100-A
Company Name
Peak Medical Distribution Inc.
Labeler DUNS
078393632
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-06-05
Public Version
1
Public Version Date
2023-06-13
Public Version Status
New
Public Device Record Key
9ae8d185-594a-45f8-ae8c-64f02b7cae15

Device Description

Cannula tip for Automatic Washer Flushing System for Enhanced Flushing of Clear Flush Kerrison. 10/Box: UDI G453CFK100A0

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
Yes
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
GEA Cannula, Surgical, General & Plastic Surgery

GMDN Terms

Code Name
35210 Exploratory blunt needle, single-use

Identifiers

Type ID
Primary G453CFK100A0