FDA.reportPublic FDA data

ATRAMAT

Primary DI
07500142155772
Brand
ATRAMAT
Company
Internacional Farmacéutica, S.A. de C.V.
Model
CATGUT SIMPLE
Catalog number
SR2621-75
Device description
ATRAMAT PLAIN GUT SURGICAL SUTURE USP 0 EP 4, 75 CM NEEDLE SR-26 PREMIUM REGULAR TAPER POINT 26 MM 1/2 CIRCLE CATGUT SIMPLE USP 0, 75 CM AGUJA SR-26 A
Published
2018-07-13
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
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
07500142155772PackageGS112In Commercial Distribution
07500142055775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07500142155772075001421557727500142155772
07500142055775075001420557757500142055775

GMDN Terms#

Term, Definition table
TermDefinition
Catgut suture, plainA sterile, 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 needle intended to be disposed of after single use. 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
Length26Millimeter

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
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
true
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

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Primary DI, Brand, Company table
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05055445928193SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928209SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
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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
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