BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Vistec

DI: 10884527016891 · Model: 6297 · Cardinal Health, Inc.

View on AccessGUDID

Product Codes

1

GMDN Terms

1

Identifiers

3

Pkg Device Count

1000

Basic Information

Brand Name: Vistec
Primary DI: 10884527016891
Version / Model: 6297
Catalog Number: 6297
Company Name: Cardinal Health, Inc.
Labeler DUNS: 080935429
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1000
Record Status: Published
Publish Date: 2018-06-30
Public Version: 3
Public Version Date: 2021-08-24
Public Version Status: Update
Public Device Record Key: 44057e2a-2a09-47f5-9e53-545da1a795a7

Device Description

X-Ray Detectable Sponges,Round Cotton-filled, Medium

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
Over the Counter (OTC): Yes
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: Yes
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
Package	20884527016898	GS1	CASE	2000	In Commercial Distribution
Primary	10884527016891	GS1
Unit of Use	30884527016895	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	1.3125	Inch

Storage Conditions

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