BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Vistec

DI: 10884521131903 · Model: VS4416 · Cardinal Health, Inc.

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1800

Basic Information

Brand Name: Vistec
Primary DI: 10884521131903
Version / Model: VS4416
Catalog Number: VS4416
Company Name: Cardinal Health, Inc.
Labeler DUNS: 080935429
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1800
Record Status: Published
Publish Date: 2018-06-27
Public Version: 3
Public Version Date: 2021-08-24
Public Version Status: Update
Public Device Record Key: 0fdd2198-e24f-468d-ac3e-9799d6203b8a

Device Description

X-Ray Detectable Sponges,16 Ply

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
Over the Counter (OTC): Yes
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: Yes
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GDY	GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE	General, Plastic Surgery	878.4450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38496	Radiopaque woven surgical sponge	A non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521131903	GS1
Unit of Use	20884521131900	GS1

Customer Contacts

Phone: +1(508)261-8000
Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	4	Inch
Length	4	Inch

Storage Conditions

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