FDA.reportPublic FDA data

DemeBOND

Primary DI
30652927784306
Brand
DemeBOND
Company
DEMETECH CORPORATION
Model
PB4x1042026C6P20SF
Device description
Polyester Multifilament Coated,Braided, Sterile, Nonabsorbable Suture
Published
2023-09-27
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
GATSuture, Nonabsorbable, Synthetic, Polyethylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023030000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023030000DEMETECH POLYESTER NONABSORBABLE SUTUREDemetech Corp.2003-06-18GAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30652927784306PackageGS112In Commercial Distribution
10652927784302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3065292778430630652927784306
1065292778430210652927784302

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, non-bioabsorbable, multifilamentA multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester 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. It is not a barbed suture and does not include antimicrobial agents/materials. 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
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
07899258654799Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258654805Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258654812Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258654829Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258657141Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665764Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665771Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665795Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665863Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665870Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665894Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665962Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665986Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258697864Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258697871Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258697888Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258697895Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258697901Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698038Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698045Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698052Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698069Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698076Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698083Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698090Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698106Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698113Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698120Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698137Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698144Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27