FDA.report

CARDINAL HEALTH

Primary DI
10885380103421
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
D2862-20A
Catalog number
D2862-20A
Device description
SURG STER BLADES SZ20 SS, STERILE USE W/HANDLE D2861-4 12EA/BX 12BX/CS
Published
2019-04-29
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
EMFKNIFE, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMFKnife, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20885380103428PackageGS112In Commercial Distribution
50885380103429PackageGS112In Commercial Distribution
10885380103421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088538010342820885380103428
5088538010342950885380103429
1088538010342110885380103421

GMDN Terms

TermDefinition
Scalpel blade, single-useA sterile interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity25 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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