FDA.reportPublic FDA data

DemeGUT

Primary DI
10652927100027
Brand
DemeGUT
Company
Demetech Corporation
Model
CC1020026G4
Device description
Chromic Gut, Sterile, Absorbable Surgical Suture
Published
2017-03-21
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

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
K072930000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072930000DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUTDemetech Corp.2008-04-30GAL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30652927100021PackageGS112In Commercial Distribution
10652927100027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3065292710002130652927100021
1065292710002710652927100027

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.

Regulatory Flags#

DUNS number
039436691
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10652927777540DemeFORCEFR390226B0P2026-04-20
10652927778240DemeFORCEFR312022026-04-20
10652927778257DemeFORCEFR312052026-04-20
10652927778264DemeFORCEFR312202026-04-20
10652927778271DemeFORCEFR35022026-04-20
10652927778288DemeFORCEFR35052026-04-20
10652927778295DemeFORCEFR35202026-04-20
10652927784890DemeDIOX BarbedPXB2982026B0U12026-04-20
10652927784951DemeDIOX BarbedPXB2983026B0U12026-04-20
10652927785132DemeDIOX BarbedPXB280148C0B2026-04-20
10652927785569DemeDIOX BarbedPXB883017B0U12026-04-20
10652927785606DemeFORCEFR350240B5P2026-04-20
10652927785613DemeFORCEFR4x350548B6P2026-04-20
10652927785644DemeDIOX BarbedPXB1182026B0U12026-04-20
10652927785651DemeDIOX BarbedPXB1183026B0U12026-04-20
10652927785699DemeDIOX BarbedPXB880037B0U12026-04-20
10652927785705DemeDIOX BarbedPXB882037B0U12026-04-20
10652927785835DemeDIOX BarbedPXB180140B0U12026-04-20
10652927785842DemeDIOX BarbedPXB180148B0U12026-04-20
10652927785965DemeDIOX BarbedPXB5383026B0U12026-04-20

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