FDA.reportPublic FDA data

Ziptek knotless tissue repair and attachment devices

Primary DI
00858816006101
Brand
Ziptek knotless tissue repair and attachment devices
Company
ZIPTEK LLC
Model
B56-793-S_D
Catalog number
01
Device description
Ziptek large stainless steel driver/handle assembly reusable medical grade stainless steel ofr use with large 5.0mm screws and biocomposite plugs and as ZipE capture/button pusher
Published
2024-07-19
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
LRZScrewdriver, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRZScrewdriver, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858816006101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858816006101008588160061018588160061010858816006101

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
035237962
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
00858816006071ZipE Knotless Tissue Repair and attachment devicesc7-50160-ss712024-07-19
00858816006088Ziptek knotless tissue repair and attachment devicesB56-635-S_D882024-07-19
00858816006064ZipE Knotless Tissue Repair and Attachment DevicesRb41-S-4642024-06-03
10858816006061Zip E® Knotless Tissue Repair and Attachment DevicesRb41-S-4612024-06-03
10858816006009ZipE® Knotless Tissue Repair and Attachment DevicesRA6-6550-S2019-06-04
10858816006016ZipE® Knotless Tissue Repair and Attachment DevicesRA6-6565-S2019-06-04
10858816006023ZipE® Knotless Tissue Repair and Attachment DevicesA6-6550-S2019-06-04
10858816006030ZipE® Knotless Tissue Repair and Attachment DevicesA6-6545-S2019-06-04
00858816006002ZipE® Knotless Tissue Repair and Attachment DevicesRA6-6550-S2018-09-20
00858816006019ZipE® Knotless Tissue Repair and Attachment DevicesRA6-6565-S2018-09-20
00858816006026ZipE® Knotless Tissue Repair and Attachment DevicesA6-6550-S2018-09-20
00858816006033ZipE® Knotless Tissue Repair and Attachment DevicesA6-6545-S2018-09-20

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