Insightec Exablate 2100V1 - Page 29

SAFETY
Manual Part Number
29
Symbol
Symbol Title
Description
Standard Reference
Authorized
representative in
the European
Community
This symbol shall be accompanied by the
name and address of the authorized
representative in the European
Community.
ISO 15223-1: 2016,
clause 5.1.2
Prescription
devices
Caution: Federal law restricts this device to
sale by or on the order of a physician /
special practitioner.
21 CFR 801.109
21 CFR
801.15(c)(1)(i)F
Manufacturer
This symbol shall be accompanied by the
name and address of the manufacturer.
ISO 15223-1: 2016,
clause 5.1.1
Date of
manufacture
This symbol shall be accompanied by a date
to indicate the date of manufacture.
ISO 15223-1: 2016,
clause 5.1.3
Use-by date
This symbol shall be accompanied by a date
to indicate the expiration date.
ISO 15223-1: 2016,
clause 5.1.4
Batch code
This symbol shall be accompanied by the
manufacturer’s batch code. The batch code
shall be adjacent to the symbol.
ISO 15223-1: 2016,
clause 5.15
Serial number
This symbol shall be accompanied by the
manufacturer’s serial number.
ISO 15223-1: 2016,
clause 5.1.7
Catalogue
number
The manufacturer’s catalogue number shall
be adjacent to the symbol.
ISO 15223-1: 2016,
clause 5.1.6
Model
Model/ Type
designation
The name and/or number used to
represent one medical device, or a family of
medical devices to group many variations
that have shared characteristics.
IMDRF/RPS WG/N
19:2016
Keep away from
sunlight/ Keep
away from heat
Indicates a medical device that needs
protection from light sources.
ISO 15223-1: 2016,
clause 5.3.2