FDA.reportPublic FDA data

Plain Gut

Primary DI
10884521548336
Brand
Plain Gut
Company
Covidien LP
Model
CSK11170V
Device description
Absorbable Suture
Published
2017-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K142656000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142656000Surgical Gut SutureCovidien2015-01-29GAL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521548333PackageGS124In Commercial Distribution
10884521548336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452154833320884521548333
1088452154833610884521548336

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
Length18Inch

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521824355McGRATHX3-003-0002021-09-01
10884521032903BiosynGMT-2262015-09-01
10884521073517VersaportNBFCA5ST2016-09-24
10884521085329SofsilkGSJ-36-M2015-09-01
10884521085336SofsilkGSJ-37-M2015-09-01
10884521101999Vascufil88864722-21V2015-08-31
10884521191013Endo GIAEGIATRS60AMT2015-09-01
10884521543522Tri-Staple 2.0SIGC60VT2017-05-26
10884521543638Tri-Staple 2.0SIGTRS60AMT2017-05-26
10884521726352ReliaTackRELTACK8RDPTSW2018-06-03
10884523000627SILSSILSHOOK362016-09-24
10884523000917Surgiwand II1780942016-09-24
10884523006599Premium Plus CEEA1119852015-08-28
10884524001500ValleylabE2516HS2016-09-24
10884521195202SonicisionSCD132018-08-10
10884521807884SonicisionSCD132020-06-29
10884521546219LigaSureLIGASUREZD2018-09-08
10884521845985INVOSPMC71VP-GE2025-07-03
10884521063150ILA3948L2015-08-28
10884521102422Steel88862345-532015-08-31

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