Trephine 11mm ID

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 10-074-000

by Symmetry Medical Manufacturing, Inc.

Identity

Trade Name: Trephine 22mm ID FDA UDI
Generic Name: Bone trephine, reusable FDA UDI
Device Name: Trephine 11mm ID EUDAMED
Trephine 22mm ID FDA UDI
Model / Reference: 10-074-000 EUDAMEDFDA UDI
Description: Trephine 22mm ID FDA UDI

Identifiers

Catalog Number: 2709-05-220;00-9986-040-36 FDA UDI
Primary DI / UDI-DI: 00847538001716 EUDAMEDFDA UDI
Basic UDI-DI: 08475380141472D EUDAMED
Direct Marketing DI: 00847538001716 EUDAMED
FDA Product Code: HWK FDA UDI
EMDN Code: L090902 ORTHOPAEDIC SURGERY TREPHINES, REUSABLE EUDAMED
GMDN Term: Bone trephine, reusable FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Market of Registration: Ireland EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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: Bone trephine, reusable

The Trephine 11mm ID medical device, Symmetry Medical Polymacrylate (SMP), is a Class IIa implantable device designed for near-patient testing. With a near-patient testing capability of none and human tissues of zero, it is not suitable for this purpose. The device's Sterilization status is Sterile, indicating that it has undergone the necessary procedures to ensure its purity. It is also Reusable, indicating that it can be used multiple times with proper cleaning and maintenance. The Trephine 11mm ID is a widely approved medical device, having an Approved Release for Medical Device (AR) number of -197.

Similar devices

Also classified as Bone trephine, reusable.

Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
Integra® Jarit® — Integra LifeSciences Production Corporation · Class II
DENTECH — Dentech Corp. · Class I
Karl Schumacher — KARL SCHUMACHER DENTAL, LLC · Class I
ZOLL-DENTAL — Zoll-Dental · Class I
Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
Borchardt Flat Trephine 5 mm Borchardt Shaft Ø 1.8 mm Stainless Steel — SURTEX INSTRUMENTS LTD · Class I

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	08475380141472D	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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

Manufacturer

Manufacturer: Symmetry Medical Manufacturing, Inc.
EUDAMED SRN: US-MF-000025394
Authorised Representative: SYMMETRY MEDICAL POLYVAC FR-AR-000003187

Sources (2)

EUDAMED 379414f3-8990-41d0-bb82-a46fd087632d 61 fields · synced Jun 23, 2026
FDA UDI df43cc8e-ff45-4176-afc4-30843ac660bf 34 fields · synced May 24, 2026