FDA.reportPublic FDA data

ATRAMAT

Primary DI
07500142105548
Brand
ATRAMAT
Company
Internacional Farmacéutica, S.A. de C.V.
Model
CHROMIC GUT
Catalog number
CE1216-75
Device description
ATRAMAT CHROMIC GUT SURGICAL SUTURE USP 6-0 EP 1, 75 CM NEEDLE CE-12 REVERSE CUTTING 12 MM 3/8 CIRCLE
Published
2021-03-08
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
GALSuture, Absorbable, Natural

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GALSuture, Absorbable, NaturalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K911354000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K911354000STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURESInternacional Farmaceutica, S.A. DE C.V.1991-10-25GAL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07500142105548PackageGS112In Commercial Distribution
07500142005541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07500142105548075001421055487500142105548
07500142005541075001420055417500142005541

GMDN Terms#

Term, Definition table
TermDefinition
Catgut suture, chromicA single-strand (monofilament), natural, bioabsorbable thread composed mostly of collagen fibres derived from mammals (e.g., sheep or bovine intestines), impregnated with chromium salts to increase tensile strength and retard absorption, 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 device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by enzymatic degradation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length12Millimeter

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
+525511050260CUSTOMER.CARE@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
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
10652927111276DemeGUTDemetech CorporationGAL2019-07-22
10652927121824DemeGUTDemetech CorporationGAL2019-07-22
10652927129097DemeGUTDemetech CorporationGAL2019-07-22
10652927148821DemeGUTDemetech CorporationGAL2019-07-22
10652927150497DemeGUTDemetech CorporationGAL2019-07-22
10652927150503DemeGUTDemetech CorporationGAL2019-07-22
10652927152620DemeGUTDemetech CorporationGAL2019-07-22
10652927158448DemeGUTDemetech CorporationGAL2019-07-22
10652927158516DemeGUTDemetech CorporationGAL2019-07-22
10652927158547DemeGUTDemetech CorporationGAL2019-07-22
10652927158820DemeGUTDemetech CorporationGAL2019-07-22
10652927159322DemeGUTDemetech CorporationGAL2019-07-22
10652927159339DemeGUTDemetech CorporationGAL2019-07-22
10652927159346DemeGUTDemetech CorporationGAL2019-07-22
10652927159353DemeGUTDemetech CorporationGAL2019-07-22
10652927159360DemeGUTDemetech CorporationGAL2019-07-22
10652927160984DemeGUTDemetech CorporationGAL2019-07-22
10652927160991DemeGUTDemetech CorporationGAL2019-07-22
10652927161004DemeGUTDemetech CorporationGAL2019-07-22
10652927162117DemeGUTDemetech CorporationGAL2019-07-22
10652927163978DemeGUTDemetech CorporationGAL2019-07-22
10652927165361DemeGUTDemetech CorporationGAL2019-07-22
10652927170112DemeGUTDemetech CorporationGAL2019-07-22
10652927177678DemeGUTDemetech CorporationGAL2019-07-22
10652927185246DemeGUTDemetech CorporationGAL2019-07-22
10652927188438DemeGUTDemetech CorporationGAL2019-07-22
10652927194088DemeGUTDemetech CorporationGAL2019-07-22
10652927197508DemeGUTDemetech CorporationGAL2019-07-22
10652927198604DemeGUTDemetech CorporationGAL2019-07-22
10652927199489DemeGUTDemetech CorporationGAL2019-07-22