FDA UDI In Commercial Distribution 🇺🇸 United States

Jac-cell USA Inc.

DI: B461JAU142213 · Model: JAU-1422 · JAC CELL USA INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
60

Basic Information

Brand Name
Jac-cell USA Inc.
Primary DI
B461JAU142213
Version / Model
JAU-1422
Company Name
JAC CELL USA INC
Labeler DUNS
015023538
Distribution Status
In Commercial Distribution
Device Count in Pkg
60
Record Status
Published
Publish Date
2017-02-15
Public Version
3
Public Version Date
2019-02-07
Public Version Status
Update
Public Device Record Key
f4ca521b-d8eb-4097-985e-1940ecee4603

Device Description

PENCIL, Push Button w/SS Blade&Holster Disposable

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
No
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
GEI Electrosurgical, Cutting & Coagulation & Accessories

GMDN Terms

Code Name
61869 Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

Identifiers

Type ID
Primary B461JAU142213
Unit of Use B461JAU142202