FDA.reportPublic FDA data

Syneture

Primary DI
20884521746364
Brand
Syneture
Company
Covidien LP
Model
8886470401V-2
Catalog number
8886470401V-2
Device description
Coated Monofilament Polybutester,CV-Coated Monofilament Polybutester
Published
2020-07-19
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
K990952000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990952000NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURESUnited States Surgical, A Division of Tyco Healthc1999-04-01GAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521746364PackageGS136In Commercial Distribution
10884521746367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452174636420884521746364
1088452174636710884521746367

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, non-bioabsorbable, monofilamentA single-strand (monofilament), synthetic thread made from a non-bioabsorbable polyester (e.g., polybutester) 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. 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length30Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;
Storage Environment Temperature0 Degrees Fahrenheit130 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
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
10884521703827Tri-Staple 2.0SIGCIR21MTORVIL2026-08-09
10884521703834Tri-Staple 2.0SIGCIR21XTORVIL2026-08-09
10884521703841Tri-Staple 2.0SIGCIR25MTORVIL2026-08-09
10884521703858Tri-Staple 2.0SIGCIR25XTORVIL2026-08-09
10884521782648ValleylabE105202021-07-12
10884521703797Tri-Staple 2.0SIGCIR21XT2026-07-31
10884521703810Tri-Staple 2.0SIGCIR25XT2026-07-31
10884521102163Vascufil88864788-05V2015-08-31
10884522006545Shiley10DCFS2015-08-28
10884522030021Shiley5.0 PDL2015-09-15
10884522030083Shiley6.0 PDL2015-09-15
20884522029022Shiley8DCT2015-08-31
20884522029114Shiley4.5PDC2015-10-20
20884522031957Shiley10LPC-S2015-08-28
20884522031964Shiley4LPC-S2015-08-28
20884522031988Shiley8LPC-S2017-05-25
30884522026653Shiley3.0 NEO2015-09-15
30884522026684Shiley4.5 NEO2015-10-12
10884521833869EndoflipEF-301-RFB2024-04-12
10884521855359GI GeniusGGM300-US-RFB2026-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860007711251EasyWhipWinter Innovations Inc.GAT2026-08-01
00860007711275EasyWhipWinter Innovations Inc.GAT2026-08-01
00860014630712EasyWhipWinter Innovations Inc.GAT2026-08-01
00860014630743EasyWhipWinter Innovations Inc.GAT2026-08-01
00860014630750EasyWhipWinter Innovations Inc.GAT2026-08-01
00860014630767EasyWhipWinter Innovations Inc.GAT2026-08-01
14026704724441DEKNATELTELEFLEX INCORPORATEDGAT2026-08-01
14026704724861DEKNATELTELEFLEX INCORPORATEDGAT2026-08-01
14026704725042DEKNATELTELEFLEX INCORPORATEDGAT2026-08-01
14026704723857DEKNATELTELEFLEX INCORPORATEDGAT2026-07-29
10705031097889ETHIBOND EXCELETHICON, LLCGAT2026-07-17
10705031102996ETHIBOND EXCELETHICON, LLCGAT2026-07-17
10705031103085ETHIBOND EXCELETHICON, LLCGAT2026-07-17
10705031238404ETHIBOND EXCELETHICON, LLCGAT2026-07-17
10705031461963ETHIBOND EXCELETHICON, LLCGAT2026-07-17
10705031461970ETHIBOND EXCELETHICON, LLCGAT2026-07-17
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