DEVICE: HYGITECH (03615140003322)
Device Identifier (DI) Information
HYGITECH
HY-60025
In Commercial Distribution
HY-60025
HYGITECH
HY-60025
In Commercial Distribution
HY-60025
HYGITECH
Cover the patient and keep his eyes uncovered.
U-shaped cutout on the shorter side with adhesive for easy positioning and fixing around the collar.
Size of the U cutout: diameter 11.5 cm, height 10 cm.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| Yes | |
| Yes | |
| No | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 62934 | Surgical dressing/drape kit, single-use |
A collection of various types of patient drapes, dressings, covers and/or towels intended to be used to facilitate a surgical procedure. It does not include any pharmaceuticals, surgical instruments, surgical tubing, or mechanically functional devices and is not dedicated to catheterization support. This is a single-use device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| FXP | Cover, Shoe, Operating-Room |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
ad630aac-5862-4687-98fc-de51a19e740e
June 22, 2021
4
November 25, 2020
June 22, 2021
4
November 25, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 03615140003339 | 25 | 03615140003322 | In Commercial Distribution | Box | |
| 03615140003346 | 2 | 03615140003339 | In Commercial Distribution | Carton |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined