Straightshot

FDA UDI

Class II (US FDA UDI)

by DePuy Mitek, Inc.

Identity

Trade Name: STRAIGHTSHOT FDA UDI
Generic Name: Orthopaedic guidewire, single-use FDA UDI
Device Name: STRAIGHTSHOT LIGAMENT GRAFT PASSER/PROTECTOR 10.5mm FDA UDI
Model / Reference: 232215 FDA UDI
Description: STRAIGHTSHOT LIGAMENT GRAFT PASSER/PROTECTOR 10.5mm FDA UDI

Identifiers

Catalog Number: 232215 FDA UDI
Primary DI / UDI-DI: 10886705011049 FDA UDI
510(k) Number: K934366 FDA UDI
FDA Product Code: JDW FDA UDI
HWC FDA UDI
GMDN Term: Orthopaedic guidewire, single-use FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthopaedic guidewire, single-use

Straightshot by DePuy Mitek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthopaedic guidewire, single-use.

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Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
2.7mm Guidewire, Drill Tip, 300mm — OsteoCentric Technologies,Inc · Class I
Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
Ball Tip Wire — Orthopedic Designs North America, Inc. · Class I
HINGE PEDIATRIC PLATING SYSTEM — Orthopediatrics Canada ULC · Class I

Cleared under the same submission

K934366 also covers:

STRAIGHTSHOT — DePuy Mitek, Inc.

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

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Manufacturer

Manufacturer: DePuy Mitek, Inc.

Sources (1)

FDA UDI 91243af6-d93e-4fe6-9ca9-d16c55744562 36 fields · synced Jun 8, 2026