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
00848782052417SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052424SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052431SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052448SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052462SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052486SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052684SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052691SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052707SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052714SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052721SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052738SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052745SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052752SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052776SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052783SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052790SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052806SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052813SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052820SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052837SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052844SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052851SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052875SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052882SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052899SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052905SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052912SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052929SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052936SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06