FDA.reportPublic FDA data

DemeGUT

Primary DI
30652927245227
Brand
DemeGUT
Company
DEMETECH TRADING CORPORATION
Model
CC1020136B0P
Device description
Chromic Gut, Sterile, Absorbable Surgical Suture
Published
2019-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
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
30652927245227PackageGS11In Commercial Distribution
10652927245223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3065292724522730652927245227
1065292724522310652927245223

GMDN Terms#

Term, Definition table
TermDefinition
Catgut suture, chromicA sterile, 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 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3058241048info@demetech.us

Regulatory Flags#

DUNS number
039436691
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30652927197373DemeGUTCC1020140B0P2019-06-04
30652927197441DemeGUTCP1030140B0P2019-06-04
30652927206938DemeGUTCC1020148B0P2019-06-04
30652927213042DemeGUTCC1020150B0P2019-06-04
30652927214940DemeGUTCC1020148B4P2019-06-04
30652927214957DemeGUTCC1020050B0P2019-06-04
30652927222167DemeGUTCC1020037B0P2019-06-04
30652927222174DemeGUTCC1020040B0P2019-06-04
30652927239127DemeGUTCC1020137B0P2019-06-04
30652927239134DemeGUTCC1020237B0P2019-06-04
30652927239165DemeGUTCC1020148B6P2019-06-04
30652927244350DemeGUTCC1020240B0P2019-06-04
30652927255431DemeGUTCC1020130B0P2019-06-04
30652927259675DemeGUTCP1030040B0P2019-06-04
30652927263368DemeGUTCC1020140F4P2019-06-04
30652927267045DemeGUTCP1030136B0P2019-06-04
30652927268110DemeGUTCC1020236B0P2019-06-04
30652927268639DemeGUTCC1020145B0P2019-06-04
30652927287722DemeLONNL1060030F4P2019-06-04
30652927402255DemeGUTCP1030148B0P2019-06-04

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