FDA.reportPublic FDA data

DEKNATEL

Primary DI
44026704591822
Brand
DEKNATEL
Company
TELEFLEX INCORPORATED
Model
IPN011422
Catalog number
D-7507K
Device description
DEK MX BL MF 7-0 XT-6.5 2N 30"
Published
2015-10-16
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
24026704591828PackageGS11In Commercial Distribution
44026704591822PackageGS136In Commercial Distribution
04026704591824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670459182824026704591828
4402670459182244026704591822
04026704591824040267045918244026704591824

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 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
Length75Centimeter

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
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

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