FDA.reportPublic FDA data

PGA RESORBA

Primary DI
E203OD03701
Brand
PGA RESORBA
Company
Resorba Medical GmbH
Model
PGA RESORBA
Published
2019-08-09
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
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143584000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143584000PGA RESORBA, PGA RESOQUICK, GLYCOLONResorba Medical GmbH2015-11-02GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E203OD03701PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, multifilamentA multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polyester intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable needle. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition.

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

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Primary DI, Brand, Company table
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