FDA.reportPublic FDA data

V-Loc 90 Delta

Primary DI
08809766324540
Brand
V-Loc 90 Delta
Company
Samyang Holdings Corporation
Model
VLOCDM2005
Catalog number
VLOCDM2005
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
OTC
false
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
08809766324540PackageGS112In Commercial Distribution
08809766324533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809766324540088097663245408809766324540
08809766324533088097663245338809766324533

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
Length6Inch

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
695439951
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
true
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
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
08809766324878V-Loc 90 DeltaVLOCDM0124VLOCDM01242023-05-31
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10705031464384STRATAFIXETHICON, LLCGAM2023-03-24
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10705031464407STRATAFIXETHICON, LLCGAM2023-03-24
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10705031464421STRATAFIXETHICON, LLCGAM2023-03-24
10705031464438STRATAFIXETHICON, LLCGAM2023-03-24