DEVICE: HYGITECH (03615140003506)

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Device Record History
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Device Identifier (DI) Information
HYGITECH
HY-60010
In Commercial Distribution
HY-60010
HYGITECH
03615140003506
GS1

1
279456896 *Terms of Use
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.
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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
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FDA Product Code

[?]
Product Code Product Code Name
KKX Drape, Surgical
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
390c7eee-f775-4442-9dd2-1181c89bf6c0
June 22, 2021
4
November 25, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
03615140003513 50 03615140003506 In Commercial Distribution Box
03615140003520 2 03615140003513 In Commercial Distribution Carton
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
Yes CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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