FDA.reportPublic FDA data

DemeLON

Primary DI
30652927287722
Brand
DemeLON
Company
DEMETECH TRADING CORPORATION
Model
NL1060030F4P
Device description
Nylon Monofilament, Sterile, Nonabsorbable 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
GARSuture, Nonabsorbable, Synthetic, Polyamide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GARSuture, Nonabsorbable, Synthetic, PolyamideGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023028000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023028000DEMETECH NYLON NONABSORBABLE SUTUREDemetech Corp.2003-06-18GAR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30652927287722PackageGS112In Commercial Distribution
10652927287728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3065292728772230652927287722
1065292728772810652927287728

GMDN Terms#

Term, Definition table
TermDefinition
Nylon suture, non-bioabsorbable, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) 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. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition.

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
30652927245227DemeGUTCC1020136B0P2019-06-04
30652927255431DemeGUTCC1020130B0P2019-06-04
30652927259675DemeGUTCP1030040B0P2019-06-04
30652927263368DemeGUTCC1020140F4P2019-06-04
30652927267045DemeGUTCP1030136B0P2019-06-04
30652927268110DemeGUTCC1020236B0P2019-06-04
30652927268639DemeGUTCC1020145B0P2019-06-04
30652927402255DemeGUTCP1030148B0P2019-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07757093013747SUTUMEDUnilene S.A.C.GAR2024-09-19
07757093013891SUTUMEDUnilene S.A.C.GAR2024-09-19
07757093013068SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013280SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013563SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013587SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013600SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013877SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013952SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014041SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014096SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014188SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014362SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014393SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014560SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014713SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014744SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014768SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014881SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014898SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014911SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015048SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015093SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015147SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015253SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015277SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015284SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015437SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015482SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015741SUTUMEDUnilene S.A.C.GAR2023-01-06