AccessGUDID - DEVICE: Kendall (20192253052883)

GUDID

Device Identifier (DI) Information

Brand Name: Kendall
Version or Model: 41556
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 41556
Company Name: Cardinal Health 200, LLC

Primary DI Number: 20192253052883
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2025
Device Count: 2
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: LARGE WINGED SPONGES WITH PVP-I SCRUB

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35567	Surgical personnel scrub preparation kit	A collection of devices designed for preoperative preparation of surgical personnel, e.g., scrubbing the fingers, hands and forearms, prior to gloving and donning surgical apparel. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEC	BRUSH, SCRUB, OPERATING-ROOM

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fa8de1f3-6ec1-4126-82e2-1028db57cc37
Public Version Date: June 30, 2025
Public Version Number: 4
DI Record Publish Date: July 26, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50192253052884	10	20192253052883	2025-06-30	Not in Commercial Distribution	CASE

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 10192253052886 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

No Customer Contact currently defined

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