FDA.report

CARDINAL HEALTH

Primary DI
30885380133859
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
C-SG448ZS
Catalog number
C-SG448ZS
Device description
-Premium Gauze Sponges -4 x 4 in (10.2 x 10.2 cm) -8-Ply -USP Type VII Gauze
Published
2019-09-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
NABGauze / sponge,nonresorbable for external use

Product Code Classifications

CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30885380133859PackageGS164In Commercial Distribution
50885380133853PackageGS12In Commercial Distribution
20885380133852PrimaryGS10
10885380133855Unit of UseGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorConversion note
3088538013385914308853801338593Indicator 3 usually represents packaging or variable measure; UPC/EAN conversion is not shown.
5088538013385314508853801338535Indicator 5 usually represents packaging or variable measure; UPC/EAN conversion is not shown.
2088538013385214208853801338522Indicator 2 usually represents packaging or variable measure; UPC/EAN conversion is not shown.
1088538013385514108853801338551Indicator 1 usually represents packaging or variable measure; UPC/EAN conversion is not shown.

GMDN Terms

TermDefinition
Woven surgical spongeA non-medicated sterile 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 does not contain special features to help detect gossypiboma (sponge left inside patient). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
10
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
false
No natural rubber latex
false
Sterilization required before use
false

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