FDA.reportPublic FDA data

SprayShield

Primary DI
10884521057906
Brand
SprayShield
Company
Covidien LP
Model
SSK01
Catalog number
SSK01
Device description
Adhesion Barrier System
Published
2016-04-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MCNBarrier, Absorable, Adhesion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCNBarrier, Absorbable, AdhesionUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521057906PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452105790610884521057906

GMDN Terms#

Term, Definition table
TermDefinition
Surgical anti-adhesion dressing, implantable, bioabsorbableA bioabsorbable, surgically-implanted device intended to prevent the abnormal fibrous union (adhesion) between one internal body part/tissue to another following a surgical procedure. The device is typically implanted during abdominal or pelvic surgery to reduce the incidence of adhesions between adjacent anatomical structures. It is typically made of a modified cellulose material.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth0.01Inch
Height0.01Inch
Width0.01Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit120 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
058614483
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521758803Vascufil8886470311V-22020-07-19
20884521082868VersaStepVS1015052016-09-24
10884521038967ValleylabE250510FRNSB2025-03-27
10884524002880ValleylabE250510FRNSB2025-03-27
10884521039100ValleylabE3310NSB2016-09-24
10884521141117WarmTouch50308902019-02-06
10884521205024Shiley4CN65R2016-09-24
10884521205420Shiley5CN70R2016-09-24
10884521205437Shiley6CN75R2016-09-24
10884521205444Shiley7CN80R2016-09-24
10884521205451Shiley8CN85R2016-09-24
10884521205468Shiley9CN90R2016-09-24
10884521205475Shiley10CN10R2016-09-24
10884521205482Shiley4UN65R2016-09-24
10884521205499Shiley5UN70R2016-09-24
10884521205505Shiley6UN75R2016-09-24
10884521205512Shiley7UN80R2016-09-24
10884521205529Shiley8UN85R2016-09-24
10884521205536Shiley9UN90R2016-09-24
10884521205543Shiley10UN10R2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03770016478038Womed LeafWOMEDMCN2025-12-24
03770016478045Womed LeafWOMEDMCN2025-12-24
03770016478052Womed LeafWOMEDMCN2025-12-24
05413765589614SEPRAFILMBAXTER HEALTHCARE CORPORATIONMCN2021-06-10
05413765589621SEPRAFILMBAXTER HEALTHCARE CORPORATIONMCN2021-06-10
05413765589638SEPRAFILMBAXTER HEALTHCARE CORPORATIONMCN2021-06-10
05413765589645SEPRAFILMBAXTER HEALTHCARE CORPORATIONMCN2021-06-10
05413765589652SEPRAFILMBAXTER HEALTHCARE CORPORATIONMCN2021-06-10
35413765589615SEPRAFILMBAXTER HEALTHCARE CORPORATIONMCN2021-06-10
35413765589622SEPRAFILMBAXTER HEALTHCARE CORPORATIONMCN2021-06-10
35413765589639SEPRAFILMBAXTER HEALTHCARE CORPORATIONMCN2021-06-10
35413765589646SEPRAFILMBAXTER HEALTHCARE CORPORATIONMCN2021-06-10
35413765589653SEPRAFILMBAXTER HEALTHCARE CORPORATIONMCN2021-06-10
00085412086217Adept Adhesion Reduction Solution BAXTER INTERNATIONAL INC.MCN2017-03-23
00358468430120Seprafilm®GENZYME CORPORATIONMCN2014-09-24
00358468508621Seprafilm® Procedure PackGENZYME CORPORATIONMCN2014-09-24
00358468638014Seprafilm® 4-sectionGENZYME CORPORATIONMCN2014-09-24
00358468664112Seprafilm® Single SiteGENZYME CORPORATIONMCN2014-09-24
00358468664211Seprafilm® Small IncisionGENZYME CORPORATIONMCN2014-09-24
10705031005396GYNECARE INTERCEEDEthicon SàrlMCN2014-09-20
10705031147843GYNECARE INTERCEEDETHICON, LLCMCN2014-09-20
20705031147840GYNECARE INTERCEEDETHICON, LLCMCN2014-09-20
20705031005393GYNECARE INTERCEEDETHICON, LLCMCN2014-09-20