FDA.report

CONVERTORS

Primary DI
50630140930438
Brand
CONVERTORS
Company
Cardinal Health 200, LLC
Model
5550-
Catalog number
5550-
Device description
Absorbent Towel Bulk Non sterile
Published
2019-09-23
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
PUIDrape, surgical, exempt

Product Code Classifications

CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50630140930438PrimaryGS10
10630140930430Unit 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
5063014093043814506301409304385Indicator 5 usually represents packaging or variable measure; UPC/EAN conversion is not shown.
1063014093043014106301409304301Indicator 1 usually represents packaging or variable measure; UPC/EAN conversion is not shown.

GMDN Terms

TermDefinition
Surgical towelA sterile cloth used in the operating room (OR) to absorb extraneous fluids. This is a single-use device.

Sterilization Methods

Method
Ethylene Oxide

Regulatory Flags

DUNS number
961027315
Device count
300
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
true
Sterilization required before use
true

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