FDA UDI In Commercial Distribution 🇺🇸 United States

Venom

DI: 07613327118612 · Model: 0406860225 · STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Venom
Primary DI
07613327118612
Version / Model
0406860225
Catalog Number
0406860225
Company Name
STRYKER CORPORATION
Labeler DUNS
196548481
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-23
Public Version
4
Public Version Date
2023-05-03
Public Version Status
Update
Public Device Record Key
2ae9e810-1423-4019-9c05-11433913c20c

Device Description

RF Cannula, CVD

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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
GXI PROBE, RADIOFREQUENCY LESION

GMDN Terms

Code Name
58739 Percutaneous radio-frequency ablation probe cannula, single-use

Identifiers

Type ID
Package 37613327118613
Primary 07613327118612

Customer Contacts

Device Sizes

Type Value Unit Text
Device Size Text, specify Distal Length: 150.0 Millimeter
Length 169.9 Millimeter
Needle Gauge 18.0 Gauge
Device Size Text, specify Diameter: 1.25 Millimeter

Storage Conditions

Type
Storage Environment Atmospheric Pressure
Temperature Range
50 – 106 KiloPascal
Type
Storage Environment Humidity
Temperature Range
10 – 75 Percent (%) Relative Humidity
Type
Storage Environment Temperature
Temperature Range
-34 – 65 Degrees Celsius