FDA.report

Curity

Primary DI
20884521060460
Brand
Curity
Company
Cardinal Health, Inc.
Model
8045
Catalog number
8045
Device description
All Purpose Sponges,Nonwoven, 4 Ply
Published
2018-06-30
Public version status
Update
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

Contact Domains

Product Codes

CodeName
FRLFIBER, MEDICAL, ABSORBENT

Product Code Classifications

CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20884521060460PackageGS150In Commercial Distribution
30884521060467PackageGS1800In Commercial Distribution
10884521060463PrimaryGS10
40884521060464Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088452106046020884521060460
3088452106046730884521060467
1088452106046310884521060463
4088452106046440884521060464

GMDN Terms

TermDefinition
Woven gauze padA non-medicated device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it does not include petrolatum. It is typically used to: clean, cover, or pack wounds or abrasions and absorb their exudates; absorb body-surface exudates; or apply topical medications. This is a single-use device.

Device Sizes

TypeValueUnit
Length4Inch
Width4Inch

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00This side up;

Sterilization Methods

Method

Contacts

PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags

DUNS number
080935429
Device count
5
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
false
Sterilization required before use
false

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