FDA.reportPublic FDA data

LAPRA-TY

Primary DI
20705031206882
Brand
LAPRA-TY
Company
Johnson & Johnson International Inc.
Model
XC200
Catalog number
XC200
Device description
Violet Polydioxanone Polymer, Synthetic Absorbable Suture Clips
Published
2015-09-25
Public version status
Update
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
FZPCLIP, IMPLANTABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZPClip, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K931492000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931492000LAPRA-TY* SUTURE CLIPETHICON, Inc.1993-08-24FZP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705031206882PackageGS16In Commercial Distribution
10705031206885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503120688220705031206882
1070503120688510705031206885

GMDN Terms#

Term, Definition table
TermDefinition
Suture clasp, bioabsorbableA small, sterile, implantable fastening device intended to be used to secure the ends of a suture as an alternative to tying a knot, for approximation of soft tissue and/or prosthetic materials during a surgical procedure. The device is typically made of a polymer (e.g., polydioxanone) that is gradually degraded and digested by body tissues; it is typically implanted with a dedicated applicator.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify0025
Special Storage Condition, Specify00Degrees Celsius
Special Storage Condition, Specify00Storage Environment Temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266xxx@xxx.xxx

Regulatory Flags#

DUNS number
372587696
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
10705031038783Coated VICRYLJ322HJ322H2015-09-01
10705031038806Coated VICRYLJ323HJ323H2015-09-01
10705031039131Coated VICRYLJ347HJ347H2015-09-23
10705031039292Coated VICRYLJ363HJ363H2015-09-23
10705031038653Coated VICRYLJ306HJ306H2015-09-01
10705031038738Coated VICRYLJ316HJ316H2015-09-01
10705031038875Coated VICRYLJ329HJ329H2015-09-01
10705031038950Coated VICRYLJ335HJ335H2015-09-01
10705031039278Coated VICRYLJ359HJ359H2015-09-01
10705031039315Coated VICRYLJ364HJ364H2015-09-01
10705031039339Coated VICRYLJ365HJ365H2015-09-01
10705031039391Coated VICRYLJ371HJ371H2015-09-01
10705031039704Coated VICRYLJ418HJ418H2015-09-01
10705031040076Coated VICRYLJ459HJ459H2015-09-01
10705031040090Coated VICRYLJ460HJ460H2015-09-01
10705031040113Coated VICRYLJ461HJ461H2015-09-01
10705031040199Coated VICRYLJ467HJ467H2015-09-01
10705031040298Coated VICRYLJ474HJ474H2015-09-01
10705031040397Coated VICRYLJ486HJ486H2015-09-01
10705031040595Coated VICRYLJ496HJ496H2015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04717480902064InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902101InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902149InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902170InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902217InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902293InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
08904255203877MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255203938MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255203945MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255203952MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225503MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225510MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225527MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225534MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225541MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225558MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
14026704725301WECKTELEFLEX INCORPORATEDFZP2025-07-03
14026704613868WECKTELEFLEX INCORPORATEDFZP2025-05-13
14026704613875WECKTELEFLEX INCORPORATEDFZP2025-05-13
14026704613844WECKTELEFLEX INCORPORATEDFZP2025-04-28
14026704613851WECKTELEFLEX INCORPORATEDFZP2025-04-24
14026704725264WECKTELEFLEX INCORPORATEDFZP2024-03-13
14026704725271WECKTELEFLEX INCORPORATEDFZP2024-03-13
14026704725288WECKTELEFLEX INCORPORATEDFZP2024-03-13
14026704725295WECKTELEFLEX INCORPORATEDFZP2024-03-13
14026704725318WECKTELEFLEX INCORPORATEDFZP2024-03-13
10193489144765MedlineMEDLINE INDUSTRIES, INC.FZP2023-12-20
10193489144789MedlineMEDLINE INDUSTRIES, INC.FZP2023-12-20
10193489144796MedlineMEDLINE INDUSTRIES, INC.FZP2023-12-20
10193489144819MedlineMEDLINE INDUSTRIES, INC.FZP2023-12-20