FDA.report

DEKNATEL

Primary DI
34026704424505
Brand
DEKNATEL
Company
TELEFLEX INCORPORATED
Model
IPN026329
Catalog number
V-1204
Device description
V-PAK (XB79-774GW)X10
Published
2018-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OVNSuture kit

Product Code Classifications

CodeDeviceSpecialtyClass
OVNSuture KitGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34026704424505PackageGS112In Commercial Distribution
04026704424504PreviousGS10
14026704424501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3402670442450534026704424505
04026704424504040267044245044026704424504
1402670442450114026704424501

GMDN Terms

TermDefinition
Suture kit, non-medicatedA collection of sterile instruments and dressings necessary to perform a suturing procedure; it does not contain any pharmaceuticals. It typically includes a disinfectant, needles and various threads (sutures used to join the edges of a wound or incision by stitching), drapes, swabs, needle holder, and other single-use disposable devices. This device may be used in a wide variety of clinical settings and some types may be used for the removal of sutures. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length30Inch

Sterilization Methods

Method

Contacts

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
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 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 DIBrandCompanyProduct codePublished
20809160515157MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OVN2026-03-05
50198956254730CARDINAL HEALTHCardinal Health 200, LLCOVN2026-03-03
50198956369359CARDINAL HEALTHCardinal Health 200, LLCOVN2026-03-02
50198956410815CARDINAL HEALTHCardinal Health 200, LLCOVN2026-03-02
50198956377477CARDINAL HEALTHCardinal Health 200, LLCOVN2026-02-23
50198956318388CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-30
20809160509750MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OVN2026-01-21
50198956325133CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-13
50198956201840CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-29
50198956299977CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-29
50198956285710CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-22
50198956249866CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-17
50198956250053CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-17
50198956192964CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-11
50198956199628CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-09
50198956279795CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-09
50198956241846CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-28
50198956284560CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-25
50198956284676CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-25
50198956233520CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-17
50198956185126CARDINAL HEALTHCardinal Health 200, LLCOVN2025-09-23
50198956192889CARDINAL HEALTHCardinal Health 200, LLCOVN2025-09-22
20809160494896Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OVN2025-09-19
50198956132311CARDINAL HEALTHCardinal Health 200, LLCOVN2025-09-04
20809160493585Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OVN2025-09-04
20809160493257Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OVN2025-09-02
50198956170795CARDINAL HEALTHCardinal Health 200, LLCOVN2025-08-19
50198956160345CARDINAL HEALTHCardinal Health 200, LLCOVN2025-08-05
50198956150131CARDINAL HEALTHCardinal Health 200, LLCOVN2025-07-28
50198956132083CARDINAL HEALTHCardinal Health 200, LLCOVN2025-07-11