ZipE Knotless Tissue Repair and attachment devices

FDA UDI

Class I (US FDA UDI)

by Ziptek, LLC

Identity

Trade Name: ZipE Knotless Tissue Repair and attachment devices FDA UDI
Generic Name: Surgical tamp, reusable FDA UDI
Device Name: ZipE® resusable medical grade stainless steel punch tool FDA UDI
Model / Reference: c7-50160-ss FDA UDI
Description: ZipE® resusable medical grade stainless steel punch tool FDA UDI

Identifiers

Catalog Number: 71 FDA UDI
Primary DI / UDI-DI: 00858816006071 FDA UDI
FDA Product Code: LRY FDA UDI
GMDN Term: Surgical tamp, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical tamp, reusable

ZipE Knotless Tissue Repair and attachment devices by Ziptek, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Ziptek, LLC

Sources (1)

FDA UDI aafe5c4d-be26-49a0-b991-845b3bf516ba 34 fields · synced Jun 8, 2026