FDA.reportPublic FDA data

ATRAMAT

Primary DI
07500142045844
Brand
ATRAMAT
Company
Internacional Farmacéutica, S.A. de C.V.
Model
POLIPROPILENO
Catalog number
P-PE1964
Device description
ATRAMAT POLYPROPYLENE SURGICAL SUTURE BLUE USP 4-0 EP 1,5, 45 CM NEEDLE P-PE-19 SUPRA-SHARP REVERSE CUTTING 19 MM 3/8 CIRCLEPOLIPROPILENO AZUL USP 4-0, 45 CM AGUJA P-PE-19 REVERSO CORTANTE SUPRA-SHARP 19 MM 3/8 CIRCULO
Published
2016-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K911189000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K911189000STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTUREInternacional Farmaceutica, S.A. DE C.V.1991-04-25GAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07500142145841PackageGS112In Commercial Distribution
07500142045844PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07500142145841075001421458417500142145841
07500142045844075001420458447500142045844

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 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.

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
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

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
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