FDA.reportPublic FDA data

KLOSURE

Primary DI
00812444028492
Brand
KLOSURE
Company
RIVERPOINT MEDICAL, LLC
Model
P1011C
Device description
Suture
Published
2018-06-25
Public version status
Update
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
00812444028492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812444028492008124440284928124440284920812444028492

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
964053560
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840277412010ApeTapeP63-21B-2040-012026-05-22
00840277412027ApeTapeP63-21W-2040-012026-05-22
00840277405609LigaMend™ (Black)102.0002026-03-19
00840277405616LigaMend™ (Blue)112.0002026-03-19
00840277405623LigaMend™105.0002026-03-19
00840277405630Strut Suture103.0002026-03-19
00840277405715LigaMend™ Soft Button (Black)106.0002026-03-19
00840277405722LigaMend™ Soft Button (Blue)116.0002026-03-19
00840277411358No-Tie Button111.0002026-03-19
10810020085218HS FiberHS1652026-03-16
10840277411768HS FiberHS2412026-03-16
10840277411775HS FiberHS2422026-03-16
10840277411782HS FiberHS2432026-03-16
10840277411799HS FiberHS2442026-03-16
00840277411808HS FiberHS2452026-03-16
10840277411812Gold MarkerGM0453-20202026-03-11
00812444029673OrthoButton ALOBAL802026-03-03
00840277411068HS FiberDFX00182026-01-26
00840277411396HS FiberHS9032026-01-13
10840277411409HS FiberHS9042026-01-13

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