FDA UDI In Commercial Distribution 🇺🇸 United States

HYGITECH

DI: 03615140003568 · Model: HY-50018 · HYGITECH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
HYGITECH
Primary DI
03615140003568
Version / Model
HY-50018
Catalog Number
HY-50018
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
1
Public Version Date
2020-12-23
Public Version Status
New
Public Device Record Key
c40c29d3-89d1-4f20-8fa3-7e3e03fab24b

Device Description

Astronaut cap HYGITECH Reference: HY-50018 Ultimate protection: - Recommended for long or high-risk surgeries - It holds back loose hair and is ideal for medium to long hair - Fixes with 2 non-woven ties for the best protection and comfort - Only the face remains uncovered, head, neck and ears are protected

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
FYF Cap, Surgical

GMDN Terms

Code Name
12535 Medical equipment drape, single-use

Identifiers

Type ID
Package 03615140003575
Primary 03615140003568