FDA.reportPublic FDA data

FILAMIDE

Primary DI
18904255203140
Brand
FILAMIDE
Company
MERIL ENDO SURGERY PRIVATE LIMITED
Model
NYL401667
Catalog number
NYL401667
Device description
Non-absorbable Polyamide Surgical Suture
Published
2018-11-03
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
GARSuture, Nonabsorbable, Synthetic, Polyamide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GARSuture, Nonabsorbable, Synthetic, PolyamideGeneral, 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
18904255203140PrimaryGS10
08904255203143Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1890425520314018904255203140
08904255203143089042552031438904255203143

GMDN Terms#

Term, Definition table
TermDefinition
Nylon suture, non-bioabsorbable, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) 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 needle intended to be disposed of after single use. The thread provides temporary wound support until the wound sufficiently heals. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition.

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
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07757093013600SUTUMEDUnilene S.A.C.GAR2023-01-06
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07757093013952SUTUMEDUnilene S.A.C.GAR2023-01-06
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07757093014881SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014898SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014911SUTUMEDUnilene S.A.C.GAR2023-01-06
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