FDA.reportPublic FDA data

RESOPREN

Primary DI
E203US77151
Brand
RESOPREN
Company
Resorba Medical GmbH
Model
RESOPREN
Published
2019-02-01
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
MXWSuture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MXWSuture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)General, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143582000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143582000MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEELResorba Medical GmbH2015-10-29GAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E203US77151PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polyvinylidene fluoride sutureA sterile, single-strand (monofilament), synthetic, non-bioabsorbable thread made of polyvinlyidene fluoride intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress; it can be removed from the tissue once wound healing occurs or allowed to remain in the tissue where it is gradually encapsulated by fibrous connective tissue. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341053195
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E203US80216POLYESTERPOLYESTER2019-01-31
E203US80217POLYESTERPOLYESTER2019-01-31
E203US8112POLYESTERPOLYESTER2019-01-31
E203US81422POLYESTERPOLYESTER2019-01-31
E203US81423POLYESTERPOLYESTER2019-01-31
E203US81428POLYESTERPOLYESTER2019-01-31
E203US90210SUPOLENESUPOLENE2019-02-03
E203US90214SUPOLENESUPOLENE2019-02-03
E203US90219SUPOLENESUPOLENE2019-02-03
E203US90220SUPOLENESUPOLENE2019-02-03
E203US90223SUPOLENESUPOLENE2019-02-03
E203US90225SUPOLENESUPOLENE2019-02-03
E203US90230SUPOLENESUPOLENE2019-02-03
E203US90231SUPOLENESUPOLENE2019-02-03
E203US9026SUPOLENESUPOLENE2019-02-03
E203US9027SUPOLENESUPOLENE2019-02-03
E203US9028SUPOLENESUPOLENE2019-02-03
E203US9038SUPOLENESUPOLENE2019-02-03
E203US90616SUPOLENESUPOLENE2019-02-03
E203US9132SUPOLENESUPOLENE2019-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E203US770210RESOPRENResorba Medical GmbHMXW2019-02-01
E203US771401RESOPRENResorba Medical GmbHMXW2019-02-01
E203US771415RESOPRENResorba Medical GmbHMXW2019-02-01
E203US771416RESOPRENResorba Medical GmbHMXW2019-02-01
E203US771517RESOPRENResorba Medical GmbHMXW2019-02-01
E203US77152RESOPRENResorba Medical GmbHMXW2019-02-01
E203US771520RESOPRENResorba Medical GmbHMXW2019-02-01
E203US771524RESOPRENResorba Medical GmbHMXW2019-02-01
E203US771525RESOPRENResorba Medical GmbHMXW2019-02-01
E203US771526RESOPRENResorba Medical GmbHMXW2019-02-01
E203US771527RESOPRENResorba Medical GmbHMXW2019-02-01
E203US77153RESOPRENResorba Medical GmbHMXW2019-02-01
E203US771534RESOPRENResorba Medical GmbHMXW2019-02-01
E203US77154RESOPRENResorba Medical GmbHMXW2019-02-01
E203US77155RESOPRENResorba Medical GmbHMXW2019-02-01