AccessGUDID - DEVICE: HCS (00849027004246)

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GUDID

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Device Identifier (DI) Information

Brand Name: HCS
Version or Model: HCS1513-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DYAD MEDICAL SOURCING, LLC

Primary DI Number: 00849027004246
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 078572603 *Terms of Use

Device Description: Knit Briefs, Reusable and Seamless, XXXXL with White Band, 2/Bag

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Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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?
41588	Incontinence pants, single-use	An underwear designed to retain urine leakage in incontinent adults and older children. It typically consists of a single-use man?s brief or woman?s panty with external softness and shape resembling regular underwear, and an internal pad and/or isolated shell capable of retaining the urine of patients with light or medium incontinence while keeping the skin dry. The device is used in healthcare facilities or at home.	Active	false

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FDA Product Code

Product Code	Product Code Name
EYQ	Garment, Protective, For Incontinence

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FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: 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

Public Device Record Key: acd4a4e4-88a4-4b8a-a847-82a0944f4cc8
Public Version Date: January 08, 2020
Public Version Number: 1
DI Record Publish Date: December 31, 2019

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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
10849027004243	50	00849027004246		In Commercial Distribution	case

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Secondary DI

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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Unit of Use DI

Unit of Use DI Number: 20849027004240 CLOSE

Direct Marking (DM)

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
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Production Identifier(s) in UDI

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

No Customer Contact currently defined

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