FDA.report

Vistec

Primary DI
50192253045602
Brand
Vistec
Company
Cardinal Health 200, LLC
Model
1069
Catalog number
1069
Device description
Vistec X-Ray Detectable Sponges
Published
2024-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
GDYGauze/sponge, internal, x-ray detectable

Product Code Classifications

CodeDeviceSpecialtyClass
GDYGauze/Sponge, Internal, X-Ray DetectableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50192253045602PackageGS14In Commercial Distribution
20192253045601PrimaryGS10
10192253045604Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225304560250192253045602
2019225304560120192253045601
1019225304560410192253045604

GMDN Terms

TermDefinition
Radiopaque woven surgical spongeA 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
250
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50192253050293VistecCardinal Health 200, LLCGDY2026-03-05
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10815555025630CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025623CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025647CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025654CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
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