FDA.reportPublic FDA data

DEKNATEL

Primary DI
34026704633419
Brand
DEKNATEL
Company
TELEFLEX INCORPORATED
Model
IPN029160
Catalog number
DM-4760
Device description
DEKLENE MAXX BLUE MONOFILAMENT 3-0 C-2 2N 36" PS
Published
2018-07-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAWSuture, Nonabsorbable, Synthetic, PolypropyleneGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34026704633419PackageGS136In Commercial Distribution
04026704591961PreviousGS10
14026704633415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3402670463341934026704633419
04026704591961040267045919614026704591961
1402670463341514026704633415

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin suture, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene, polytetrafluoroethylene, polyvinylidene fluoride) 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 to withstand normal stress. 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
Length90Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00none

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
08903837747532Polypropylene sutureHEALTHIUM MEDTECH LIMITEDGAW2026-05-25
03661522101278COROLENE®PETERS SURGICALGAW2026-03-09
03661522101919COROLENE®PETERS SURGICALGAW2026-03-06
03661522101926COROLENE®PETERS SURGICALGAW2026-03-06
03661522101933COROLENE®PETERS SURGICALGAW2026-03-06
03661522101940COROLENE®PETERS SURGICALGAW2026-03-06
03661522101957COROLENE®PETERS SURGICALGAW2026-03-06
03661522101971COROLENE®PETERS SURGICALGAW2026-03-06
03661522101988COROLENE®PETERS SURGICALGAW2026-03-06
03661522101995COROLENE®PETERS SURGICALGAW2026-03-06
03661522102008COROLENE®PETERS SURGICALGAW2026-03-06
03661522102015COROLENE®PETERS SURGICALGAW2026-03-06
03661522102022COROLENE®PETERS SURGICALGAW2026-03-06
03661522102039COROLENE®PETERS SURGICALGAW2026-03-06
03661522102046COROLENE®PETERS SURGICALGAW2026-03-06
03661522102053COROLENE®PETERS SURGICALGAW2026-03-06
03661522102060COROLENE®PETERS SURGICALGAW2026-03-06
03661522102077COROLENE®PETERS SURGICALGAW2026-03-06
03661522102084COROLENE®PETERS SURGICALGAW2026-03-06
03661522102091COROLENE®PETERS SURGICALGAW2026-03-06
03661522102107COROLENE®PETERS SURGICALGAW2026-03-06
03661522102114COROLENE®PETERS SURGICALGAW2026-03-06
03661522102121COROLENE®PETERS SURGICALGAW2026-03-06
03661522102138COROLENE®PETERS SURGICALGAW2026-03-06
03661522102145COROLENE®PETERS SURGICALGAW2026-03-06
03661522102152COROLENE®PETERS SURGICALGAW2026-03-06
03661522102169COROLENE®PETERS SURGICALGAW2026-03-06
03661522102176COROLENE®PETERS SURGICALGAW2026-03-06
03661522102183COROLENE®PETERS SURGICALGAW2026-03-06
03661522102190COROLENE®PETERS SURGICALGAW2026-03-06