DIGITALIS INSTRUMENTS DDGI201043

GUDID 08057717559880

BRM EXTREMITIES SRL

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID08057717559880
NIH Device Record Key6d0fdbee-25eb-4916-8268-8621a58c1c29
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIGITALIS INSTRUMENTS
Version Model NumberSilicon MCP Trial size 4
Catalog NumberDDGI201043
Company DUNS435126746
Company NameBRM EXTREMITIES SRL
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.

Device Identifiers

Device Issuing AgencyDevice ID
GS108057717559880 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08057717559880]

Moist Heat or Steam Sterilization

[08057717559880]

Moist Heat or Steam Sterilization

[08057717559880]

Moist Heat or Steam Sterilization

[08057717559880]

Moist Heat or Steam Sterilization

[08057717559880]

Moist Heat or Steam Sterilization

[08057717559880]

Moist Heat or Steam Sterilization

[08057717559880]

Moist Heat or Steam Sterilization

[08057717559880]

Moist Heat or Steam Sterilization

[08057717559880]

Moist Heat or Steam Sterilization

[08057717559880]

Moist Heat or Steam Sterilization

[08057717559880]

Moist Heat or Steam Sterilization

[08057717559880]

Moist Heat or Steam Sterilization

[08057717559880]

Moist Heat or Steam Sterilization

[08057717559880]

Moist Heat or Steam Sterilization

[08057717559880]

Moist Heat or Steam Sterilization

[08057717559880]

Moist Heat or Steam Sterilization

[08057717559880]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-11
Device Publish Date2024-04-03

On-Brand Devices [DIGITALIS INSTRUMENTS ]

08057717559996Digitalis Box
08057717559989Digitalis Small Sterilization Box
08057717559972Digitalis MCP Reamer
08057717559965Digitalis PIP Reamer
08057717559958Digitalis MCP Rasp
08057717559941Digitalis PIP Rasp
08057717559934Silicon PIP Trial size 4
08057717559927Silicon PIP Trial size 3
08057717559910Silicon PIP Trial size 2
08057717559903Silicon PIP Trial size 1
08057717559897Silicon MCP Trial size 5
08057717559880Silicon MCP Trial size 4
08057717559873Silicon MCP Trial size 3
08057717559866Silicon MCP Trial size 2
08057717559859Silicon MCP Trial size 1
08057717559842Digitalis complete Instruments Set
08057717559835Multisize Trial MCP
08057717559828Multisize Trial PIP
08057717559811Digitalis Handle
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