FDA UDI In Commercial Distribution 🇺🇸 United States

HYGITECH

DI: 03615140003759 · Model: HY-620 · HYGITECH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
HYGITECH
Primary DI
03615140003759
Version / Model
HY-620
Catalog Number
HY-620
Company Name
HYGITECH
Labeler DUNS
279456896
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-11-25
Public Version
4
Public Version Date
2021-06-22
Public Version Status
Update
Public Device Record Key
5bc380b9-228c-4cad-bc52-175f25b6f494

Device Description

Sterile dual layered surgical drape, absorbent and impermeable, ensures the best protection! Cover the patient and keep his eyes covered. Dimension : 100 x 160 with off-centered hole Drape with an oval opening of 10.5 x 12 cm diameter with adhesive around the centre of the drape for easy positioning and fixing over the patient's face and particularly around the mouth.

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
Yes

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
KKX Drape, Surgical

GMDN Terms

Code Name
62934 Surgical dressing/drape kit, single-use

Identifiers

Type ID
Package 03615140003766
Primary 03615140003759
Package 03615140003773