FDA.reportPublic FDA data

Dermacea

Primary DI
20884521174877
Brand
Dermacea
Company
Cardinal Health, Inc.
Model
441200
Catalog number
441200
Device description
Super Sponges,Medium
Published
2018-06-27
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRLFIBER, MEDICAL, ABSORBENT
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521174877PackageGS1480In Commercial Distribution
10884521174870PrimaryGS10
30884521174874Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452117487720884521174877
1088452117487010884521174870
3088452117487430884521174874

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze padA non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6.75Inch
Width6Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00This side up;

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521156159Monoject8934CRS8934CRS2017-01-06
10884521156173Monoject8985CRH8985CRH2017-01-07
20884521156200Monoject8985CRS8985CRS2017-01-07
20884521156217Monoject8989CRH8989CRH2017-01-07
10884521010444Monoject888147127388814712732018-06-30
10884521157682Curity2022A2022A2018-06-22
10884521195547Monoject1180327114E1180327114E2018-06-22
20884521195506Monoject1180323114E1180323114E2018-06-22
40884521010438Monoject888147123288814712322018-06-30
40884521018311SharpSafety8535Y8535Y2017-01-07
40884521018380Monoject8970Y8970Y2017-01-06
10884521742390Monoject888135278888813527882019-05-17
10884527006786Monoject888135278888813527882016-09-24
10884521131897VistecVS4332VS43322018-06-30
30884527004755Kendall50007363500073632016-09-24
10884521028258Kangaroo6746696746692019-11-27
10884521069343Dover888766526288876652622016-10-20
10884527010349KendallMK06860MK068602016-09-24
10884527022113Kendall3353433534-2016-09-24
10885380173691Curity6309G6309G2019-11-14

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Primary DI, Brand, Company table
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00840456203347JMUJMU DENTAL, INCNAB2026-06-23
00840456203354JMUJMU DENTAL, INCNAB2026-06-23
00840456224199JMUJMU DENTAL, INCNAB2026-06-23
00840456224205JMUJMU DENTAL, INCNAB2026-06-23
06924105625026BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
06924105625033BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
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