FDA UDI In Commercial Distribution 🇺🇸 United States

ClariFix

DI: 00868438000258 · Model: CFX-1002 · ARRINEX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
ClariFix
Primary DI
00868438000258
Version / Model
CFX-1002
Catalog Number
CFX-1002
Company Name
ARRINEX, INC.
Labeler DUNS
079807364
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-12-02
Public Version
3
Public Version Date
2022-11-28
Public Version Status
Update
Public Device Record Key
00c9278b-2a74-4d3b-8fd1-477df63d1fe1

Device Description

Cryogen Canister

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
No
Sterilization Prior Use
No

Product Codes

Code Name
GEH Unit, Cryosurgical, Accessories

GMDN Terms

Code Name
60509 Nitrous oxide gas cartridge

Identifiers

Type ID
Primary 00868438000258