FDA.reportPublic FDA data

ATRAMAT

Primary DI
07500142080418
Brand
ATRAMAT
Company
Internacional Farmacéutica, S.A. de C.V.
Model
CATGUT CROMICO
Catalog number
EZ-SS0013-150
Device description
ATRAMAT CHROMIC GUT SURGICAL SUTURE USP 3-0 EP 3, 150 CM NEEDLE EZ-SS0-0 WITHOUT NEEDLE EASY PULL 0 MM CATGUT CROMICO USP 3-0, 150 CM SIN AGUJA EASY PULL 12 SOBRES
Published
2018-07-27
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
GAIStripper, Vein, Reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAIStripper, Vein, ReusableGeneral, Plastic Surgery1

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
07500142180415PackageGS112In Commercial Distribution
07500142080418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07500142180415075001421804157500142180415
07500142080418075001420804187500142080418

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
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

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
+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
No natural rubber latex
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
05055445928162SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928179SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928186SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928193SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928209SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928216SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928223SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928230SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928247SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928254SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928261SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928407SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928414SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928421SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928438SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928445SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928452SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
00190776406523MillenniumAvalign Technologies, Inc.GAI2025-07-22
00190776406530MillenniumAvalign Technologies, Inc.GAI2025-07-22
00190776406547MillenniumAvalign Technologies, Inc.GAI2025-07-22
00190776393328MillenniumAvalign Technologies, Inc.GAI2025-05-06
00190776393762MillenniumAvalign Technologies, Inc.GAI2025-05-06
08403207004444Anmuth Medical InternationalAnmuth Medical International, LLCGAI2024-07-01
08403207004451Anmuth Medical InternationalAnmuth Medical International, LLCGAI2024-07-01
08403207004468Anmuth Medical InternationalAnmuth Medical International, LLCGAI2024-07-01
00840183505974BR Surgical, LLCBR Surgical, LLCGAI2024-06-03
00840183510206BR Surgical, LLCBR Surgical, LLCGAI2024-06-03
00840183510312BR Surgical, LLCBR Surgical, LLCGAI2024-06-03
00840183514204BR Surgical, LLCBR Surgical, LLCGAI2024-06-03
00840183517410BR Surgical, LLCBR Surgical, LLCGAI2024-06-03