PONTiS Suture-Crimp Implant

FDA UDI

Class II (US FDA UDI)

by Pontis Orthopaedics, LLC

Identity

Trade Name: PONTiS Suture-Crimp Implant FDA UDI
Generic Name: Metallic suture, multifilament FDA UDI
Device Name: PONTiS Dual Suture-Crimp Implant kit with Multifilament Stainless Steel Sutures and SS Crimp Each Kit contains: 1x Dual #3-0 MFSS sutures with 2 straight needles 1x SS Crimp collar Supplied pouched, sterilized with EO FDA UDI
Model / Reference: 400-3020 FDA UDI
Description: PONTiS Dual Suture-Crimp Implant kit with Multifilament Stainless Steel Sutures and SS Crimp Each Kit contains: 1x Dual #3-0 MFSS sutures with 2 straight needles 1x SS Crimp collar Supplied pouched, sterilized with EO FDA UDI

Identifiers

Catalog Number: 400-3020 FDA UDI
Primary DI / UDI-DI: 00859210006117 FDA UDI
FDA Product Code: GAQ FDA UDI
MBI FDA UDI
GMDN Term: Metallic suture, multifilament FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4495 FDA UDI
888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Metallic suture, multifilament

PONTiS Suture-Crimp Implant by Pontis Orthopaedics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metallic suture, multifilament.

ETHICON — Ethicon Inc. · Class II
Bioseal Inc. — BIOSEAL · Class I
DemeSTEEL — DemeTECH Corp · Class II
DemeSTEEL — DemeTECH Corp · Class II
DemeSTEEL — DemeTECH Corp · Class II
Bioseal Inc. — BIOSEAL · Class I
Bioseal Inc. — BIOSEAL · Class I
DemeSTEEL — DemeTECH Corp · Class II

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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Pontis Orthopaedics, LLC

Sources (1)

FDA UDI d12cee9e-4183-43a7-ba79-aa1b29b3696d 36 fields · synced May 30, 2026