FDA.reportPublic FDA data

Trulene

Primary DI
08903837224514
Brand
Trulene
Company
HEALTHIUM MEDTECH LIMITED
Model
EP56133-45
Published
2026-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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
08903837224514PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08903837224514089038372245148903837224514

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin/fluoropolymer suture, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., 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.

Regulatory Flags#

DUNS number
916326705
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
true
Expiration date on label
true
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
08903837224453MonoglydeE11F90CY192026-08-19
08903837224491MonoglydeE11H90CY162026-08-19
08903837224538TruleneEP66113-452026-08-19
08903837224552TruleneEP66133-452026-08-19
08903837337214MonoglydeE11F90CX19P2026-08-19
08903837337238TruleneE8H45CX13P2026-08-19
08903837337252PDSYNTHE9F75CX19P2026-08-19
08903837402325TrulonE15G75CX13P2026-08-19
08903837402349TruglydeE18F75CX19P2026-08-19
08903837402363TRUSILKE5E75CX26P2026-08-19
08903837402387TRUSILKE5H60CX16P2026-08-19
08903837799265MonoglydeE11G90CY19P2026-08-19
08903837799289MonoglydeE11G90CY16P2026-08-19
08903837799302MonoglydeE14H45CX16P2026-08-19
08903837799326TrulonE15I45CX13P2026-08-19
08903837252722Meniscal open cannulaSingle Lumen2026-08-18
08903837252746Meniscal open cannulaUp/Down2026-08-18
08903837252753Meniscal open cannulaLeft/Right2026-08-18
08903837252760Meniscal open cannulaUp Bend2026-08-18
08903837252777Meniscal open cannulaDown bend2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903837224538TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
08903837224552TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
08903837337238TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
10705031091412PROLENEETHICON, LLCGAW2026-08-17
10705031091467PROLENEETHICON, LLCGAW2026-08-17
10705031091474PROLENEETHICON, LLCGAW2026-08-17
10705031091764PROLENEETHICON, LLCGAW2026-08-17
10705031095045PROLENEETHICON, LLCGAW2026-08-17
10705031095359PROLENEETHICON, LLCGAW2026-08-17
10705031096325PROLENEETHICON, LLCGAW2026-08-17
10705031097278PROLENEETHICON, LLCGAW2026-08-17
10705031097643PROLENEETHICON, LLCGAW2026-08-17
10705031097698PROLENEETHICON, LLCGAW2026-08-17
10705031097896PROLENEETHICON, LLCGAW2026-08-17
10705031097919PROLENEETHICON, LLCGAW2026-08-17
10705031097995PROLENEETHICON, LLCGAW2026-08-17
10705031098008PROLENEETHICON, LLCGAW2026-08-17
10705031098039PROLENEETHICON, LLCGAW2026-08-17
10705031127838PROLENEETHICON, LLCGAW2026-08-17
10705031128491PROLENEETHICON, LLCGAW2026-08-17
10705031132641PROLENEETHICON, LLCGAW2026-08-17
10705031148284PROLENEETHICON, LLCGAW2026-08-17
10705031148314PROLENEETHICON, LLCGAW2026-08-17
10705031148697PROLENEETHICON, LLCGAW2026-08-17
10705031201965PROLENEETHICON, LLCGAW2026-08-17
10705031201989PROLENEETHICON, LLCGAW2026-08-17
10705031238251PROLENEETHICON, LLCGAW2026-08-17
10705031464995PROLENEETHICON, LLCGAW2026-08-17
10705031465015PROLENEETHICON, LLCGAW2026-08-17
10705031465046PROLENEETHICON, LLCGAW2026-08-17