FDA.reportPublic FDA data

PDO Max Threads

Primary DI
00850018324595
Brand
PDO Max Threads
Company
Max Pdo Inc
Model
PM19100W-SN
Catalog number
PM19100W-SN
Device description
Molded Levo Max 19gx100mm Foil Pack
Published
2021-06-23
Public version status
New
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
K190245000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190245000PDS Barbed Suture, PDO MAXX ThreadsPdo Max, Inc.2019-06-04NEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018324595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018324595008500183245958500183245950850018324595

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, monofilament, non-antimicrobialA single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) 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 device(s) [e.g., needle, passer] intended to facilitate suture application. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
043570058
Device count
1
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
00850018324700PDO Max CannulasYC-22-70 (UTW)YC-22-70 (UTW)2024-12-04
00850018324731PDO Max CannulaYC-25-50 (UTW)YC-25-50 (UTW)2024-12-04
00850018324748PDO Max CannulaYC-23-50 (UTW)YC-23-50 (UTW)2024-12-04
00850018324656PDO Max ThreadsPDO-FE-BL-02PDO-FE-BL-022022-07-20
00850018324663PDO Max ThreadsPDO-SC-BL-02PDO-SC-BL-022022-07-20
00850018324670PDO Max ThreadsPDO-SC-BL-02PDO-SC-BL-022022-07-20
00850018324687PDO Max ThreadsPDO-FE-BL-02PDO-FE-BL-022022-07-20
00850018324625PDO Max ThreadsPM18100L-SEPM18100L-SE2022-06-08
00850018324632PDO Max ThreadsPM18100L-SEPM18100L-SE2022-06-08
00850018324601PDO Max ThreadsPM2538S-DCPM2538S-DC2021-10-04
00850018324618PDO Max ThreadsPM2538S-DCPM2538S-DC2021-10-04
00850018324489PDO Max ThreadsPM2690S-CPM2690S-C2021-06-23
00850018324496PDO Max ThreadsPM2690S-CPM2690S-C2021-06-23
00850018324502PDO Max ThreadsPM2760S-CPM2760S-C2021-06-23
00850018324519PDO Max ThreadsPM2760S-CPM2760S-C2021-06-23
00850018324526PDO Max ThreadsPM2938S-CPM2938S-C2021-06-23
00850018324533PDO Max ThreadsPM2938S-CPM2938S-C2021-06-23
00850018324540PDO Max ThreadsPM2560S-CPM2560S-C2021-06-23
00850018324557PDO Max ThreadsPM2560S-CPM2560S-C2021-06-23
00850018324564PDO Max ThreadsPM18100W-SNPM18100W-SN2021-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18800145524299Miracu FCL LSCO 19Gx45mmFeeltech Co.,Ltd.NEW2026-08-25
18800145525913JBP V Line Edge 19Gx45mmFeeltech Co.,Ltd.NEW2026-08-25
18800145525920JBP V Line Force 19Gx70mmFeeltech Co.,Ltd.NEW2026-08-25
08809963477384MINTHans Biomed Corp.NEW2026-07-28
08809963477445MINTHans Biomed Corp.NEW2026-07-28
08809963477858MINTHans Biomed Corp.NEW2026-07-28
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