FDA.reportPublic FDA data

DEKNATEL

Primary DI
24026704427165
Brand
DEKNATEL
Company
TELEFLEX INCORPORATED
Model
IPN026947
Catalog number
X-5032
Device description
WHITE BRAIDED POLYESTER FIBER NONABSORBABLE SURGICAL SUTURE TAPE
Published
2017-05-10
Public version status
Update
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
MCATape, surgical, internal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCATape, Surgical, InternalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704427165PackageGS112Not in Commercial Distribution
04026704427161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670442716524026704427165
04026704427161040267044271614026704427161

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, non-bioabsorbable, multifilamentA 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
Length25.9Millimeter

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
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
10841495149457QUIKCLOT1831832026-07-17
10841495149464QUIKCLOT1831832026-07-17
10841495149471QUIKCLOT1881882026-07-17
10841495149488QUIKCLOT1881882026-07-17
10841495149495QUIKCLOT3743742026-07-17
10841495149501QUIKCLOT3743742026-07-17
10841495149518QUIKCLOT4584582026-07-17
10841495149549QUIKCLOT4594592026-07-17
10841495149563QUIKCLOT4604602026-07-17
10841495149587QUIKCLOT4614612026-07-17
10841495149600QUIKCLOT467Z467Z2026-07-17
10841495149624QUIKCLOT4874872026-07-17
14026704930644QUIKCLOT1831832026-07-17
14026704930651QUIKCLOT1831832026-07-17
14026704930668QUIKCLOT1881882026-07-17
14026704930675QUIKCLOT1881882026-07-17
14026704930682QUIKCLOT3743742026-07-17
14026704930699QUIKCLOT3743742026-07-17
14026704930705QUIKCLOT4584582026-07-17
14026704930729QUIKCLOT4594592026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10195594764692CARDINAL HEALTHCardinal Health 200, LLCMCA2022-08-12
50195594764690CARDINAL HEALTHCardinal Health 200, LLCMCA2022-08-12
34026704633174DEKNATELTELEFLEX INCORPORATEDMCA2019-09-05
34026704634003DEKNATELTELEFLEX INCORPORATEDMCA2019-09-04
14026704558947DEKNATELTELEFLEX INCORPORATEDMCA2019-01-14
34026704558941DEKNATELTELEFLEX INCORPORATEDMCA2019-01-14
34026704426363DEKNATELTELEFLEX INCORPORATEDMCA2017-12-12
34026704427445DEKNATELTELEFLEX INCORPORATEDMCA2017-08-15
34026704427452DEKNATELTELEFLEX INCORPORATEDMCA2017-08-15
04026704427161DEKNATELTELEFLEX INCORPORATEDMCA2017-05-10
04026704427444DEKNATELTELEFLEX INCORPORATEDMCA2017-05-10
04026704427451DEKNATELTELEFLEX INCORPORATEDMCA2017-05-10
24026704427448DEKNATELTELEFLEX INCORPORATEDMCA2017-05-10
24026704427455DEKNATELTELEFLEX INCORPORATEDMCA2017-05-10
34026704421962DEKNATELTELEFLEX INCORPORATEDMCA2017-04-19
34026704426264DEKNATELTELEFLEX INCORPORATEDMCA2017-04-19
34026704427254DEKNATELTELEFLEX INCORPORATEDMCA2017-04-19
24026704426151DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
24026704426267DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
24026704427257DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
24026704427462DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
04026704421794DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
04026704421800DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
04026704421817DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
04026704421961DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
04026704422005DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
04026704558940DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
24026704421798DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
24026704421804DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
24026704421811DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16