BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Kendall

DI: 40884521021915 · Model: 9255 · Cardinal Health, Inc.

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Product Codes

1

GMDN Terms

1

Identifiers

3

Pkg Device Count

1

Basic Information

Brand Name: Kendall
Primary DI: 40884521021915
Version / Model: 9255
Catalog Number: 9255
Company Name: Cardinal Health, Inc.
Labeler DUNS: 080935429
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2018-06-27
Public Version: 6
Public Version Date: 2023-04-17
Public Version Status: Update
Public Device Record Key: 35c0aa25-3a0b-4067-8ec3-6c9ea02381f8
Distribution End Date: 2023-04-15

Device Description

Hydrogel Impregnated Gauze,USP Type VII Gauze Pad 0.25 oz (7 mL) Gel

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
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: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MGQ	Dressing, wound and burn, hydrogel w/drug and/or biologic	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
47764	Wound hydrogel dressing, non-antimicrobial	A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30884521021918	GS1	CASE	100	Not in Commercial Distribution	2023-04-15
Primary	40884521021915	GS1
Package	20884521021911	GS1	PACK_OR_INNER_PACK	25	Not in Commercial Distribution	2023-04-15

Device Sizes

Type	Value	Unit	Text
Length	2	Inch
Width	2	Inch

Storage Conditions

Type: Special Storage Condition, Specify
Special Conditions: This side up;