SILKTOE INSTRUMENT BRDNPTEST40L

GUDID 08057717559644

BRM EXTREMITIES SRL

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID08057717559644
NIH Device Record Key2fdf18ed-8c26-4622-af0f-d3c258d5ef0c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSILKTOE INSTRUMENT
Version Model Number40 Left Silktoe Trial Sizer (Blue)
Catalog NumberBRDNPTEST40L
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

Device Dimensions

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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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Device Size Text, specify0
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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
GS108057717559644 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08057717559644]

Moist Heat or Steam Sterilization


[08057717559644]

Moist Heat or Steam Sterilization


[08057717559644]

Moist Heat or Steam Sterilization


[08057717559644]

Moist Heat or Steam Sterilization


[08057717559644]

Moist Heat or Steam Sterilization


[08057717559644]

Moist Heat or Steam Sterilization


[08057717559644]

Moist Heat or Steam Sterilization


[08057717559644]

Moist Heat or Steam Sterilization


[08057717559644]

Moist Heat or Steam Sterilization


[08057717559644]

Moist Heat or Steam Sterilization


[08057717559644]

Moist Heat or Steam Sterilization


[08057717559644]

Moist Heat or Steam Sterilization


[08057717559644]

Moist Heat or Steam Sterilization


[08057717559644]

Moist Heat or Steam Sterilization


[08057717559644]

Moist Heat or Steam Sterilization


[08057717559644]

Moist Heat or Steam Sterilization


[08057717559644]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-04
Device Publish Date2024-08-27

On-Brand Devices [SILKTOE INSTRUMENT]

08057717559743INSTRUMENTS SET
0805771755980420-30 SILKTOE PHALANGEAL RASP
0805771755979820-30 SILKTOE METATARSAL RASP
0805771755978135 SILKTOE PHALANGEAL RASP
0805771755977435 SILKTOE METATARSAL RASP
0805771755976740-50 SILKTOE PHALANGEAL RASP
0805771755975040-50 SILKTOE METATARSAL RASP
0805771755973620-30 SILKTOE PHALANGEAL GROMMETS IMPACTOR
0805771755972920-30 SILKTOE METATARSAL GROMMETS IMPACTOR
0805771755971235 SILKTOE PHALANGEAL GROMMETS IMPACTOR
0805771755970535 SILKTOE METATARSAL GROMMETS IMPACTOR
0805771755969940-50 SILKTOE PHALANGEAL GROMMETS IMPACTOR
0805771755968240-50 SILKTOE METATARSAL GROMMETS IMPACTOR
08057717553796SILKTOE MULTIFUNCTIONAL HANDLE
0805771755965140 Right Silktoe Trial Sizer (Blue)
0805771755967550 Right Silktoe Trial Sizer (Red)
0805771755964440 Left Silktoe Trial Sizer (Blue)
08057717559408Quick Connection Type-S

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