FDA.reportPublic FDA data

MERICRON XL

Primary DI
18904255214948
Brand
MERICRON XL
Company
MERIL ENDO SURGERY PRIVATE LIMITED
Model
PXL20513WDNZ
Catalog number
PXL20513WDNZ
Device description
Non absorbable Poly (Ethylene Terephthalate) Surgical Suture USP
Published
2018-10-04
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
GATSuture, Nonabsorbable, Synthetic, Polyethylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, 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
18904255214948PrimaryGS10
08904255214941Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1890425521494818904255214948
08904255214941089042552149418904255214941

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, non-bioabsorbable, multifilamentA multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester 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 to withstand normal stress. 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
36
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
07649990202419Drill S-PI-A1.6 extra shortSurgical Fusion Technologies GmbHGAT2026-01-18
07649990202174Geomax Reamer S-PI-A1.6Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202372Geomax Reamer S-PI-A3.0Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202389Handle SSurgical Fusion Technologies GmbHGAT2025-10-01
07649990202396Geomax Reamer SetSurgical Fusion Technologies GmbHGAT2025-10-01
07649990202228SF Push-in Anchor 1.6Surgical Fusion Technologies GmbHGAT2024-04-12
07649990202303Sonotrode S-PISurgical Fusion Technologies GmbHGAT2024-04-12
07649990202204SupraFuser B GeneratorSurgical Fusion Technologies GmbHGAT2024-02-06
07649990202020Tray_SF Push-In Anchor 2.3Surgical Fusion Technologies GmbHGAT2024-01-10
07649990202181Handpiece Front CoverSurgical Fusion Technologies GmbHGAT2024-01-10
07649990202013Tray_SF Push-in Anchor 2.3Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202037Sonotrode PI-S 2.3Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202044Twist Drill PI-C 1.8Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202051Wrench 5.0Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202150BoneWelder 150-W1Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202167SF Push-in Anchor 2.3Surgical Fusion Technologies GmbHGAT2023-12-08
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