FDA UDI In Commercial Distribution 🇺🇸 United States

Pro-Tec

DI: 00686209052028 · Model: IsoGard F2 · Dectro International
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Pro-Tec
Primary DI
00686209052028
Version / Model
IsoGard F2
Catalog Number
05-0202
Company Name
Dectro International
Labeler DUNS
246237945
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-10-09
Public Version
1
Public Version Date
2024-10-17
Public Version Status
New
Public Device Record Key
1c776279-3dfb-4e98-bc48-d4152b9fd6b1

Device Description

Hair-removal electrolysis probe, single-use

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

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
KCW Epilator, High Frequency, Needle-Type

GMDN Terms

Code Name
63883 Hair-removal electrolysis system needle electrode, single-use

Identifiers

Type ID
Primary 00686209052028