FDA.reportPublic FDA data

Excilon

Primary DI
20884521020181
Brand
Excilon
Company
Cardinal Health, Inc.
Model
7088
Catalog number
7088
Device description
AMD Antimicrobial Drain Sponges, 6 Ply, 0.2% Polyhexamethylene Biguanide HCI (PHMB)
Published
2018-06-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFQGAUZE/SPONGE, INTERNAL
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFQGauze/Sponge, InternalUnknownU
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011941000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011941000EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088The Kendall Company2001-08-22FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521020184PackageGS150In Commercial Distribution
20884521020181PackageGS1600In Commercial Distribution
00884521020187PrimaryGS10
00884521713515Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088452102018410884521020184
2088452102018120884521020181
00884521020187008845210201878845210201870884521020187
00884521713515008845217135158845217135150884521713515

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, sterileA sterile wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel) that prevents adherence to the wound bed, thereby decreasing the potential for wound trauma; it does not contain an antimicrobial agent. It is typically used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Inch
Width4Inch

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
2
DM exempt
false
Premarket exempt
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20884521148342Kendall22660A22660A2017-08-02
20884521148397Kendall31244422A31244422A2016-09-24
10884521007086Monoject118881811311888181132016-09-24
10884521007109Monoject118881910011888191002016-09-24
10884521007116Monoject118881911211888191122016-09-24
10884521007130Monoject118882011211888201122016-09-24
30884521024841Kendall923692362018-06-30
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

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