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
10884521833012BeaconN-19-052026-09-05
10884521833029BeaconN-22-052026-09-05
10884521833036BeaconN-25-052026-09-05
10884521833043SharkCoreDSC-22-012026-09-06
10884521833050SharkCoreDSC-25-012026-09-06
10884521833067SharkCoreC-22-052026-09-06
10884521833074SharkCoreC-25-052026-09-06
10884521833081SharkCoreDSL-19-012026-09-06
10884521833142BeaconDSN-19-012026-09-05
10884521833159BeaconDSN-22-012026-09-05
10884521833166BeaconDSN-25-012026-09-05
10884521197701superDimensionSDC102016-09-24
10884521198777superDimensionSDC202016-09-24
10884521198784superDimensionSDC52016-09-24
10884521198791superDimensionSDM22016-09-24
10884521198807superDimensionSDM32016-09-24
10884521539709SuperLockSDGN4472016-09-24
10884521757868Maxon8886621943-22020-01-29
10884521762688SuperLockSDGN4472021-07-05
10884521837102ILLUMISITEILS-1000-CS2024-08-09

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