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Mis 3.1 Reamer Handle Universal Conn. A.o.

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 01.11.10.0679Model MIS 3.1 reamer handle

by Hpf Srl

Identity

Trade Name
MIS 3.1 HÅNDTAG RIVALER UNIVERSAL FORB. A.O. EUDAMED
MIS 3.1 REAMER HANDLE UNIVERSAL CONN. A.O. FDA UDI
Generic Name
Burring power tool attachment FDA UDI
Model / Reference
01.11.10.0679 EUDAMEDFDA UDI
MIS 3.1 reamer handle EUDAMED

Identifiers

Primary DI / UDI-DI
08057968717985 EUDAMEDFDA UDI
Basic UDI-DI
805796871TF0032002U6 EUDAMED
Direct Marketing DI
08057968717985 EUDAMED
FDA Product Code
HWE FDA UDI
EMDN Code
L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
GMDN Term
Burring power tool attachment FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
878.4820 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Burring power tool attachment

Mis 3.1 Reamer Handle Universal Conn. A.o. by Hpf Srl — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Burring power tool attachment.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hpf Srl

Sources (2)

  • FDA UDI 3fd453c7-223d-45df-ace2-db2b998952f9 32 fields · synced Jul 12, 2026
  • EUDAMED 3311b7ea-17fd-4089-9efc-dc180e4d8e68 61 fields · synced Jul 12, 2026