FDA.reportPublic FDA data

STEEL WIRE

Primary DI
E203USL99069
Brand
STEEL WIRE
Company
Resorba Medical GmbH
Model
STEEL WIRE
Published
2019-01-21
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
GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, SterileGeneral, 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
E203USL99069PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Metallic suture, monofilamentA sterile, single-strand (monofilament), non-bioabsorbable wire made of metal (e.g., surgical steel, titanium, tantalum) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching (e.g., for abdominal wound closure, intestinal anastomosis, hernia repair), or transosseous (through bone) stitching (e.g., sternal closure); it may include an attached needle intended to be disposed of after single use. It is used primarily in orthopaedic, neurosurgical, and thoracic applications and provides temporary wound support until the wound sufficiently heals to withstand normal stress; it may be retained for permanent support. 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
10652927785309DemeSTEELDemetech CorporationGAQ2023-08-22
10652927786085DemeSTEELDemetech CorporationGAQ2023-08-22
10652927786092DemeSTEELDemetech CorporationGAQ2023-08-22
10652927777823DemeSTEELDemetech CorporationGAQ2022-12-21
10652927782926DemeSTEELDemetech CorporationGAQ2022-12-21
10652927783176DemeSTEELDemetech CorporationGAQ2022-12-21
10652927783183DemeSTEELDemetech CorporationGAQ2022-12-21
10652927783190DemeSTEELDemetech CorporationGAQ2022-12-21
10652927783206DemeSTEELDemetech CorporationGAQ2022-12-21
10652927722694DemeSTEELDemetech CorporationGAQ2020-10-13
10652927697220DemeSTEELDemetech CorporationGAQ2020-01-15
10652927669869DemeSTEELDemetech CorporationGAQ2019-12-24
10652927669876DemeSTEELDemetech CorporationGAQ2019-12-24
10652927684169DemeSTEELDemetech CorporationGAQ2019-12-24
10652927151050DemeSTEELDemetech CorporationGAQ2019-07-11
10652927161042DemeSTEELDemetech CorporationGAQ2019-07-11
10652927161172DemeSTEELDemetech CorporationGAQ2019-07-11
10652927164265DemeSTEELDemetech CorporationGAQ2019-07-11
10652927164371DemeSTEELDemetech CorporationGAQ2019-07-11
10652927165026DemeSTEELDemetech CorporationGAQ2019-07-11
10652927165033DemeSTEELDemetech CorporationGAQ2019-07-11
10652927165576DemeSTEELDemetech CorporationGAQ2019-07-11
10652927174226DemeSTEELDemetech CorporationGAQ2019-07-11
10652927174233DemeSTEELDemetech CorporationGAQ2019-07-11
10652927176909DemeSTEELDemetech CorporationGAQ2019-07-11
10652927207382DemeSTEELDemetech CorporationGAQ2019-07-11
10652927216797DemeSTEELDemetech CorporationGAQ2019-07-11
10652927216841DemeSTEELDemetech CorporationGAQ2019-07-11
10652927219736DemeSTEELDemetech CorporationGAQ2019-07-11
10652927219743DemeSTEELDemetech CorporationGAQ2019-07-11