FDA.reportPublic FDA data

DEKNATEL

Primary DI
44026704427404
Brand
DEKNATEL
Company
TELEFLEX INCORPORATED
Model
IPN026978
Catalog number
X-5538M3
Device description
STL MF 2 C-2 1N 18"X3
Published
2015-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAQSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, SterileGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704427400PackageGS11In Commercial Distribution
44026704427404PackageGS112In Commercial Distribution
04026704427406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670442740024026704427400
4402670442740444026704427404
04026704427406040267044274064026704427406

GMDN Terms#

Term, Definition table
TermDefinition
Metallic suture, monofilamentA sterile, single-strand (monofilament), non-bioabsorbable wire made of metal (e.g., surgical steel, titanium, tantalum) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching (e.g., for abdominal wound closure, intestinal anastomosis, hernia repair), or transosseous (through bone) stitching (e.g., sternal closure); it may include an attached needle intended to be disposed of after single use. It is used primarily in orthopaedic, neurosurgical, and thoracic applications and provides temporary wound support until the wound sufficiently heals to withstand normal stress; it may be retained for permanent support. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length45Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30652927785303DemeSTEELDEMETECH CORPORATIONGAQ2023-08-22
30652927786089DemeSTEELDEMETECH CORPORATIONGAQ2023-08-22
30652927786096DemeSTEELDEMETECH CORPORATIONGAQ2023-08-22
10848782046000ValkyrieSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046017ValkyrieSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046024ValkyrieSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046031ValkyrieSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046048ValkyrieSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046055ValkyrieSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046307FumedicaSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046314FSSBSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046321FumedicaSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046338FSSBSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046345FSSBSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046352FumedicaSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046369FumedicaSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046376FumedicaSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046383FumedicaSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
30652927777827DemeSTEELDemetech CorporationGAQ2022-12-21
30652927782920DemeSTEELDemetech CorporationGAQ2022-12-21
30652927783170DemeSTEELDemetech CorporationGAQ2022-12-21
30652927783187DemeSTEELDemetech CorporationGAQ2022-12-21
30652927783194DemeSTEELDemetech CorporationGAQ2022-12-21
30652927783200DemeSTEELDemetech CorporationGAQ2022-12-21
10861445000300CoNextions TR Tendon Repair System-Combo KitCONEXTIONS MEDICAL INCGAQ2022-04-28
10861445000317CoNextions TR Tendon Repair System-Deployment MechanismCONEXTIONS MEDICAL INCGAQ2022-04-28
10861445000324CoNextions TR Tendon Repair System-Implant MechanismCONEXTIONS MEDICAL INCGAQ2022-04-28
10814639025047UNIFY Stainless Surgical SuturesAPPLIED DENTAL, INC.GAQ2021-01-15
10814639025054UNIFY Stainless Surgical SuturesAPPLIED DENTAL, INC.GAQ2021-01-15
30652927722698DemeSTEELDEMETECH CORPORATIONGAQ2020-10-13