FDA.reportPublic FDA data

ATRAMAT

Primary DI
07500142134012
Brand
ATRAMAT
Company
Internacional Farmacéutica, S.A. de C.V.
Model
PGLA90
Catalog number
PE19303-B
Device description
ATRAMAT PGLA90 SURGICAL SUTURE UNDYED USP 3-0 EP 2, 70 CM NEEDLE PE-19 PREMIUM REVERSE CUTTING 19 MM 3/8 CIRCLE PGLA90 INCOLORO USP 3-0, 70 CM AGUJA P
Published
2018-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072863000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072863000ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURESInternacional Farmaceutica, S.A. DE C.V.2008-05-23GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07500142134012PackageGS112In Commercial Distribution
07500142034015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07500142134012075001421340127500142134012
07500142034015075001420340157500142034015

GMDN Terms#

Term, Definition table
TermDefinition
Poliglecaprone sutureA sterile, single-strand (monofilament), synthetic, bioabsorbable thread made of poliglecaprone (a copolymer of glycolide and E-caprolactone of low tissue reactivity) intended to join (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, and is subsequently absorbed by hydrolysis. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length19Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+525511050260ATENCION.CLIENTE@ATRAMAT.COM

Regulatory Flags#

DUNS number
811313428
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
07500142000799ATRAMATPOLIESTERS2552/22016-09-28
07500142002076ATRAMATPOLIESTERS1652/22018-07-04
07500142003172ATRAMATPOLIESTEREA855/2-452018-07-04
07500142003509ATRAMATPOLIESTERC485502018-07-09
07500142003639ATRAMATPOLIESTERW485502018-07-04
07500142005046ATRAMATPOLYESTERS1652/2-75KP62021-03-08
07500142008306ATRAMATPOLYESTERCE16542021-03-08
07500142008337ATRAMATPOLIESTEREA855/2-45B2016-09-28
07500142008375ATRAMATPOLIESTERG26522018-07-04
07500142008610ATRAMATPOLIESTERSG36512016-10-17
07500142016233ATRAMATPOLIESTERS2052/2-752018-07-04
07500142016547ATRAMATPOLIESTERSG36592018-07-17
07500142017353ATRAMATPOLIESTERSR26522016-10-18
07500142017360ATRAMATPOLIESTERSR26532016-10-14
07500142020490ATRAMATPOLIESTERS2052/2-75KP62016-09-28
07500142021268ATRAMATPOLIESTERS2552/2-KP62016-09-30
07500142025037ATRAMATPOLIESTERKW4559X42018-07-16
07500142029844ATRAMATPOLIESTERSG26522018-07-16
07500142032165ATRAMATPOLIESTERP40592018-07-12
07500142032486ATRAMATPOLIESTERPE24532018-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904255257412PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255257443PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255257450PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255257467PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255257474PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255257481PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255234369PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255234376PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255234383PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255234390PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255234406PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257306PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257313PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257320PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257337PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257344PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257351PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257368PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257375PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257382PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257399PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257405PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257429PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257436PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08903837198907MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2024-07-11
08903837198921MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2024-07-11
08903837149251MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2023-09-07
08903837149275MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2023-09-07
08903837149237MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2023-08-31
08809766324533V-Loc 90 DeltaSamyang Holdings CorporationGAM2023-05-31