Womed Leaf

Primary DI
03770016478052
Brand
Womed Leaf
Company
WOMED
Model
LEAF-L
Published
2025-12-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MCNBarrier, Absorbable, Adhesion

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P240015000
P240015001

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P240015000Womed Leaf Resorbable Adhesion BarrierWomed Sas2025-09-09MCN
P240015001Womed Leaf Resorbable Adhesion BarrierWomed Sas2025-09-09MCN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
13770016478059PackageGS11In Commercial Distribution
03770016478052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1377001647805913770016478059
03770016478052037700164780523770016478052

GMDN Terms#

Term, Definition table
TermDefinition
Surgical anti-adhesion material, nonimplantableA material intended to be placed in the body short term (<= 30 days) to prevent the abnormal fibrous union (adhesion) between one body part/tissue to another, or between one body part/tissue and a dressing, following a surgical procedure. It is made of a single or composite polymer (e.g., hydrogel, silicone) in the form of a barrier membrane or fluid dressing, and may be cut to a desired size/shape. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
270778790
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770016478038Womed LeafLEAF-S2025-12-24
03770016478045Womed LeafLEAF-M2025-12-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03770016478038Womed LeafWOMEDMCN2025-12-24
03770016478045Womed 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
10884521057906SprayShieldCovidien LPMCN2016-04-15
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