FDA.reportPublic FDA data

ATRAMAT

Primary DI
07500142113499
Brand
ATRAMAT
Company
Internacional Farmacéutica, S.A. de C.V.
Model
SEDA
Catalog number
PE2632-45
Device description
ATRAMAT SILK SURGICAL SUTURE BLACK USP 2-0 EP 3, 45 CM NEEDLE PE-26 PREMIUM REVERSE CUTTING 26 MM 3/8 CIRCLE SEDA NEGRA USP 2-0, 45 CM AGUJA PE-26 REV
Published
2016-10-14
Public version status
Update
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
GAPSuture, Nonabsorbable, Silk

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAPSuture, Nonabsorbable, SilkGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K905287000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K905287000IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURESInternacional Farmaceutica, S.A. DE C.V.1991-02-11GAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07500142113499PackageGS112In Commercial Distribution
07500142013492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07500142113499075001421134997500142113499
07500142013492075001420134927500142013492

GMDN Terms#

Term, Definition table
TermDefinition
Silk suture, sterileA sterile, natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) 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 needle. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. 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
Length26Millimeter

Storage And Handling#

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

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
true
No natural rubber latex
false
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
07757093028192SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028222SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028260SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028536SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028734SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028833SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028888SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028956SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028987SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029014SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029236SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029366SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029373SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029427SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029489SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029502SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029540SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029564SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029595SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029601SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093218463SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029809SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093029854SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093029878SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093029892SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030027SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030089SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030256SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030294SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030331SUTUMEDUnilene S.A.C.GAP2023-01-06