FDA.reportPublic FDA data

FILAPROP

Primary DI
08904255220164
Brand
FILAPROP
Company
MERIL ENDO SURGERY PRIVATE LIMITED
Model
PPL708755DN
Catalog number
PPL708755DN
Device description
MONOFILAMENT POLYPROPYLENE BLUE
Published
2019-03-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAWSuture, Nonabsorbable, Synthetic, Polypropylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAWSuture, Nonabsorbable, Synthetic, PolypropyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172149000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172149000FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical SutureM/s. Meril Endo Surgery Private Limited.2017-10-20GAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08904255220164PrimaryGS10
18904255220161Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08904255220164089042552201648904255220164
1890425522016118904255220161

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin suture, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene, polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store below 25 °C

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(609)9512287asksutures@merillife.com

Regulatory Flags#

DUNS number
870914838
Device count
12
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08904255243903PINION™ PDO Knotless SuturePNDS0102012026-05-05
08904255244009PINION™ PDO Knotless SuturePNDS0103072026-05-05
08904255244016PINION™ PDO Knotless SuturePNDS0103172026-05-05
08904255247628PINION™ PDO Knotless SuturePNDS0104042026-05-05
08904255247697PINION™ PDO Knotless SuturePNDS4006032026-05-05
08904255250536PINION™ PDO Knotless SutureThe PINION™ PDO Knotless Suture consists of barbed suPNDS010201H2026-05-05
08904255250925PINION™ PDO Knotless SuturePNDS010201XL2026-05-05
08904255251021PINION™ PDO Knotless SuturePNDS0104002026-05-05
08904255251168PINION™ PDO Knotless SuturePNDS10202BD2026-05-05
08904255252141PINION™ PDO Knotless SuturePNDS01405BD2026-05-05
08904255252158PINION™ PDO Knotless SuturePNDS0104052026-05-05
08904255252301PINION™ PDO Knotless SuturePNDS0102032026-05-05
08904255252318PINION™ PDO Knotless SuturePNDS0102052026-05-05
08904255252332PINION™ PDO Knotless SuturePNDS0104432026-05-05
08904255252349PINION™ PGA-PCL Knotless SuturePNDS0104452026-05-05
08904255252370PINION™ PDO Knotless SuturePNDS0104442026-05-05
08904255252820PINION™ PDO Knotless SuturePNDS4001202026-05-05
08904255253049PINION™ PDO Knotless SuturePNDS4004542026-05-05
08904255256422PINION™ PDO Knotless SuturePNDS010205H2026-05-05
08904255256637PINION™ PDO Knotless SuturePNDS010201XLH2026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903837037824TruleneHEALTHIUM MEDTECH LIMITEDGAW2024-07-11
07757093024767SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093024828SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093024859SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093024873SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025092SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025115SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025146SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025184SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025290SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025313SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025467SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025610SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025702SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025726SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025740SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025832SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026044SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026136SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026150SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026280SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026518SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093680543SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093023760SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023838SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023869SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023890SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023968SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093024033SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093024101SUTUMEDUnilene S.A.C.GAW2023-01-07