FDA.reportPublic FDA data

ATRAMAT

Primary DI
07500142002533
Brand
ATRAMAT
Company
Internacional Farmacéutica, S.A. de C.V.
Model
PLAIN GUT
Catalog number
CE1923-75
Device description
CATGUT SIMPLE USP 3-0, 75 CM AGUJA CE-19 REVERSO CORTANTE 19 MM 3/8 CIRCULOATRAMAT PLAIN GUT SURGICAL SUTURE USP 3-0 EP 3, 75 CM NEEDLE CE-19 REVERSE CUTTING 19 MM 3/8 CIRCLE
Published
2021-07-08
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
GALSuture, Absorbable, Natural
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GALSuture, Absorbable, NaturalGeneral, Plastic Surgery2
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, 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
07500142102530PackageGS112In Commercial Distribution
07500142002533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07500142102530075001421025307500142102530
07500142002533075001420025337500142002533

GMDN Terms#

Term, Definition table
TermDefinition
Catgut suture, plainA single-strand (monofilament), natural, bioabsorbable thread composed mostly of collagen fibres derived from mammals (e.g., sheep or bovine intestines) 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
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

Contacts#

Phone, Email table
PhoneEmail
+525511050260CUSTOMER.CARE@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
00848782052417SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052424SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052431SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052448SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052462SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052486SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052493SharpointSurgical Specialties México, S. de R.L. de C.V.GAM2026-07-06
00848782052509SharpointSurgical Specialties México, S. de R.L. de C.V.GAM2026-07-06
00848782052684SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052691SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052707SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052714SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052721SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052738SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052745SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052752SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052776SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052783SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052790SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052806SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052813SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052820SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052837SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052844SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052851SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052875SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052882SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052899SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052905SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052912SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06