FDA.reportPublic FDA data

Champion Suture Passer Ratchet Humpback

Primary DI
00860794002617
Brand
Champion Suture Passer Ratchet Humpback
Company
Lincotek Medical LLC
Model
3910-900-087
Device description
Champion Suture Passer Ratchet Humpback
Published
2024-01-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860794002617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860794002617008607940026178607940026170860794002617

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
117021487
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860794002679Versipass Suture Passer Needle472747272024-10-17
00860794002600Champion Suture Passer Ratchet Straight3910-900-0862024-01-02
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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