FDA.reportPublic FDA data

RENOVATIO

Primary DI
10850046400107
Brand
RENOVATIO
Company
Bonago Medical Solutions LLC
Model
REN-SOFT-21-60
Device description
SOFT PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
Published
2022-11-15
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
NEWSuture, Surgical, Absorbable, Polydioxanone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEWSuture, Surgical, Absorbable, PolydioxanoneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160761000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160761000DW-1CDongwon Medical Co., Ltd.2016-11-22NEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850046400107PrimaryGS10
00850046400100Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004640010710850046400107
00850046400100008500464001008500464001000850046400100

GMDN Terms#

Term, Definition table
TermDefinition
Composite-polymer sutureA multiple-strand (multifilament), synthetic thread made from strands of both a bioabsorbable polyester polymer (e.g., polydioxanone) and non-bioabsorbable polymer [e.g., polyethylene (PE)], intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues (includes use in orthopaedic surgeries). It is coated with a copolymer and may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. This is a single-use device.

Regulatory Flags#

DUNS number
118712410
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850046400251RENOVATIOREN-ALL4-18-602023-12-01
10850046400268RENOVATIOREN-ALL4-18-802023-12-01
10850046400275RENOVATIOREN-ALL4-18-1002023-12-01
00850046400254RENOVATIOREN-ALL4-18-602023-12-01
00850046400261RENOVATIOREN-ALL4-18-802023-12-01
00850046400278RENOVATIOREN-ALL4-18-1002023-12-01
10850046400015RENOVATIOREN-TWIST-27-382022-11-15
10850046400022RENOVATIOREN-TWIST-27-502022-11-15
10850046400039RENOVATIOREN-TWIST-23-902022-11-15
10850046400046RENOVATIOREN-TWIST-26-602022-11-15
10850046400053RENOVATIOREN-PUSH-23-382022-11-15
10850046400060RENOVATIOREN-MESH-19-382022-11-15
10850046400077RENOVATIOREN-MESH-19-602022-11-15
10850046400084RENOVATIOREN-RHIN-19-382022-11-15
10850046400091RENOVATIOREN-RHIN-19-502022-11-15
10850046400114RENOVATIOREN-SOFT-21-902022-11-15
10850046400121RENOVATIOREN-HARP-21-602022-11-15
10850046400138RENOVATIOREN-HARP-21-902022-11-15
10850046400145RENOVATIOREN-HARP-19-1002022-11-15
10850046400169RENOVATIOREN-HARP-18-1002022-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904255243903PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255244009PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255244016PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255247628PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255247697PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255250536PINION™ PDO Knotless SutureThe PINION™ PDO Knotless Suture consists of barbed suMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255250925PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255251021PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255251168PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252141PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252158PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252301PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252318PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252332PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252349PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252370PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252820PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255253049PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255256422PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255256637PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255256743PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255257252PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255257269PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255257276PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255234277PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-04
08904255234284PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-04
08904255234291PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-04
08904255234307PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-04
08904255234314PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-04
08904255234321PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-04