FDA.reportPublic FDA data

V-Loc 90 Delta

Primary DI
08809766324878
Brand
V-Loc 90 Delta
Company
Samyang Holdings Corporation
Model
VLOCDM0124
Catalog number
VLOCDM0124
Device description
Absorbable Wound Closure Device
Published
2023-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212810000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212810000MONOFIX PGCL, knotless wound closure deviceSamyang Holdings Corp., Ltd.2022-08-05GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809766324885PackageGS112In Commercial Distribution
08809766324878PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809766324885088097663248858809766324885
08809766324878088097663248788809766324878

GMDN Terms#

Term, Definition table
TermDefinition
Barbed polyester suture, non-antimicrobialA single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester intended to approximate the edges of a soft-tissue wound or incision by stitching. It is designed with barbs along its length intended to facilitate tissue approximation by adding tension, a fixation feature (e.g., tab, loop, bidirectional barbs) intended to eliminate the need to tie a knot, and may include disposable suture application devices [e.g., needle, passer]. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. It does not include antimicrobial agents/materials. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length18Inch

Contacts#

Phone, Email table
PhoneEmail
+82221579833hongsik.kim@samyang.com

Regulatory Flags#

DUNS number
695439951
Device count
1
Lot or batch
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809766324533V-Loc 90 DeltaVLOCDM2005VLOCDM20052023-05-31
08809766324557V-Loc 90 DeltaVLOCDM2015VLOCDM20152023-05-31
08809766324571V-Loc 90 DeltaVLOCDM2045VLOCDM20452023-05-31
08809766324595V-Loc 90 DeltaVLOCDM3335VLOCDM33352023-05-31
08809766324656V-Loc 90 DeltaVLOCDM3315VLOCDM33152023-05-31
08809766324670V-Loc 90 DeltaVLOCDM3325VLOCDM33252023-05-31
08809766324694V-Loc 90 DeltaVLOCDM4145 VLOCDM4145 2023-05-31
08809766324717V-Loc 90 DeltaVLOCDM2025VLOCDM20252023-05-31
08809766324731V-Loc 90 DeltaVLOCDM0115VLOCDM01152023-05-31
08809766324755V-Loc 90 DeltaVLOCDM2004VLOCDM20042023-05-31
08809766324793V-Loc 90 DeltaVLOCDM2044VLOCDM20442023-05-31
08809766324830V-Loc 90 DeltaVLOCDM2014VLOCDM20142023-05-31
08809766324854V-Loc 90 DeltaVLOCDM0114VLOCDM01142023-05-31
08809766324892V-Loc 90 DeltaVLOCDM0123VLOCDM01232023-05-31
08809766325875V-Loc 90 DeltaVLOCDM0133VLOCDM01332023-05-31
08809766325899V-Loc 90 DeltaVLOCDM0135VLOCDM01352023-05-31
08809766326032V-Loc 90 DeltaVLOCDM0134VLOCDM01342023-05-31
08809766326056V-Loc 90 DeltaVLOCDM0125VLOCDM01252023-05-31
08809766326070V-Loc 90 DeltaVLOCDM0113VLOCDM01132023-05-31
08809766326094V-Loc 90 DeltaVLOCDM2024VLOCDM20242023-05-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10705031464414STRATAFIXETHICON, LLCGAM2023-03-24
10705031464421STRATAFIXETHICON, LLCGAM2023-03-24
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