FDA.reportPublic FDA data

RENOVATIO

Primary DI
00850046400216
Brand
RENOVATIO
Company
Bonago Medical Solutions LLC
Model
REN-HARP-18-100-1
Device description
HARPOON PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
Published
2022-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10850046400213PrimaryGS10
00850046400216Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004640021310850046400213
00850046400216008500464002168500464002160850046400216

GMDN Terms#

Term, Definition table
TermDefinition
Polydioxanone/polyethylene sutureA multiple-strand (multifilament), synthetic thread made from strands of bioabsorbable polydioxanone and non-bioabsorbable 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118712410
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
10850046400107RENOVATIOREN-SOFT-21-602022-11-15
10850046400114RENOVATIOREN-SOFT-21-902022-11-15
10850046400121RENOVATIOREN-HARP-21-602022-11-15
10850046400138RENOVATIOREN-HARP-21-902022-11-15
10850046400145RENOVATIOREN-HARP-19-1002022-11-15

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