FDA.reportPublic FDA data

DYNEK

Primary DI
00848782042746
Brand
DYNEK
Company
Surgical Specialties México, S. de R.L. de C.V.
Model
GDP2035SE4
Catalog number
GDP2035SE4
Device description
2xHDS-18-680 P USP 2-0 Polyester green76 cm. pledgets 3x6. sterile VA6.1
Published
2021-10-22
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

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848782042743PackageGS112In Commercial Distribution
00848782042746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084878204274310848782042743
00848782042746008487820427468487820427460848782042746

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobialA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+1(877)991-1110service@surgicalspecialties.com

Regulatory Flags#

DUNS number
812762226
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848782052417SharpointB915N2026-07-06
00848782052424SharpointB926N2026-07-06
00848782052431SharpointB937N2026-07-06
00848782052448SharpointB948N2026-07-06
00848782052462SharpointC937N2026-07-06
00848782052486SharpointC959N2026-07-06
00848782052493SharpointM952N2026-07-06
00848782052509SharpointM963N2026-07-06
00848782052684SharpointB930N2026-07-06
00848782052691SharpointB931N2026-07-06
00848782052707SharpointC960N2026-07-06
00848782052714SharpointB932N2026-07-06
00848782052721SharpointB933N2026-07-06
00848782052738SharpointC961N2026-07-06
00848782052745SharpointC962N2026-07-06
00848782052752SharpointC963N2026-07-06
00848782052776SharpointC965N2026-07-06
00848782052783SharpointB934N2026-07-06
00848782052790SharpointC966N2026-07-06
00848782052806SharpointC967N2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07649990202419Drill S-PI-A1.6 extra shortSurgical Fusion Technologies GmbHGAT2026-01-18
00888867525924Arthrex®ARTHREX, INC.GAT2025-10-20
00888867525931Arthrex®ARTHREX, INC.GAT2025-10-20
07649990202174Geomax Reamer S-PI-A1.6Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202372Geomax Reamer S-PI-A3.0Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202389Handle SSurgical Fusion Technologies GmbHGAT2025-10-01
07649990202396Geomax Reamer SetSurgical Fusion Technologies GmbHGAT2025-10-01
07649990202228SF Push-in Anchor 1.6Surgical Fusion Technologies GmbHGAT2024-04-12
07649990202303Sonotrode S-PISurgical Fusion Technologies GmbHGAT2024-04-12
07649990202204SupraFuser B GeneratorSurgical Fusion Technologies GmbHGAT2024-02-06
07649990202020Tray_SF Push-In Anchor 2.3Surgical Fusion Technologies GmbHGAT2024-01-10
07649990202181Handpiece Front CoverSurgical Fusion Technologies GmbHGAT2024-01-10
07649990202013Tray_SF Push-in Anchor 2.3Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202037Sonotrode PI-S 2.3Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202044Twist Drill PI-C 1.8Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202051Wrench 5.0Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202150BoneWelder 150-W1Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202167SF Push-in Anchor 2.3Surgical Fusion Technologies GmbHGAT2023-12-08
00860007711206EasyWhipWinter Innovations Inc.GAT2021-11-18
10652927144151DemeBONDDemetech CorporationGAT2019-07-16
10652927144168DemeBONDDemetech CorporationGAT2019-07-16
10652927150312DemeBONDDemetech CorporationGAT2019-07-16
10652927158936DemeBONDDemetech CorporationGAT2019-07-16
10652927158943DemeBONDDemetech CorporationGAT2019-07-16
10652927158950DemeBONDDemetech CorporationGAT2019-07-16
10652927158967DemeBONDDemetech CorporationGAT2019-07-16
10652927158974DemeBONDDemetech CorporationGAT2019-07-16
10652927160878DemeBONDDemetech CorporationGAT2019-07-16
10652927160885DemeBONDDemetech CorporationGAT2019-07-16