FDA UDI In Commercial Distribution 🇺🇸 United States

HYGITECH

DI: 03615140002837 · Model: HY-060 · HYGITECH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
HYGITECH
Primary DI
03615140002837
Version / Model
HY-060
Catalog Number
HY-060
Company Name
HYGITECH
Labeler DUNS
279456896
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-12-15
Public Version
2
Public Version Date
2022-11-09
Public Version Status
Update
Public Device Record Key
7bbb6879-ac9f-4bbd-b26e-29fcedbb2f27

Device Description

HYGITECH polyethylene protection sleeves enable you to cover hand pieces, cables, turbines and contra-angles. Effective barrier to fight against cross contamination. Practical: Sleeves are easily separated one from another via the dispenser box. Resistant and easy to use. Sleeves must to be changed after every patient Dimensions: 4.5 or 5,5cm x45 cm long, Ø2.8 cm, conical end Ø1.5cm

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
Yes
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
Yes
Has Expiration Date
Yes
Has Donation ID
Yes

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
FTY Tape, Measuring, Rulers And Calipers

GMDN Terms

Code Name
10035 Skin surface device adhesive

Identifiers

Type ID
Package 03615140002844
Primary 03615140002837