FDA.reportPublic FDA data

Versipass Suture Passer Needle

Primary DI
00860794002679
Brand
Versipass Suture Passer Needle
Company
Lincotek Medical LLC
Model
4727
Catalog number
4727
Device description
Suture passer needle for the Versipass Suture Passer
Published
2024-10-17
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

Product Codes#

Code, Name table
CodeName
GABNeedle, Suturing, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GABNeedle, Suturing, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860794002669PackageGS15In Commercial Distribution
00860794002679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086079400266910860794002669
00860794002679008607940026798607940026790860794002679

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle, single-useA cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117021487
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860794002600Champion Suture Passer Ratchet Straight3910-900-0862024-01-02
00860794002617Champion Suture Passer Ratchet Humpback3910-900-0872024-01-02
00860794002624Champion Suture Passer Ratchet Straight Capture3910-900-0882024-01-02
00860794002631Champion Suture Passer Ratchet Humpback Capture3910-900-0892024-01-02
00860794002655Champion Suture Passer Needle3910-900-0912023-12-18
00860794002662Versipass Suture Passer47262023-12-12
B57112520006030D0Integrity-SI Fusion System1252-0006-0301252-0006-0302018-07-09
B57112520006035D0Integrity-SI Fusion System1252-0006-0351252-0006-0352018-07-09
B57112520006040D0Integrity-SI Fusion System1252-0006-0401252-0006-0402018-07-09
B57112520006045D0Integrity-SI Fusion System1252-0006-0451252-0006-0452018-07-09
B57112520006050D0Integrity-SI Fusion System1252-0006-0501252-0006-0502018-07-09
B57112520006055D0Integrity-SI Fusion System1252-0006-0551252-0006-0552018-07-09
B57112520006060D0Integrity-SI Fusion System1252-0006-0601252-0006-0602018-07-09
B57112520006065D0Integrity-SI Fusion System1252-0006-0651252-0006-0652018-07-09
B57112520006070D0Integrity-SI Fusion System1252-0006-0701252-0006-0702018-07-09
B57112521010040D0Integrity-SI Fusion System1252-1010-0401252-1010-0402018-07-09
B57112521010041D0Integrity-SI Fusion System1252-1010-0411252-1010-0412018-07-09
B57112521010045D0Integrity-SI Fusion System1252-1010-0451252-1010-0452018-07-09
B57112521010046D0Integrity-SI Fusion System1252-1010-0461252-1010-0462018-07-09
B57112521010050D0Integrity-SI Fusion System1252-1010-0501252-1010-0502018-07-09

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Primary DI, Brand, Company table
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