SILKTOE INSTRUMENT BRDNPTEST50L

GUDID 08057717559668

BRM EXTREMITIES SRL

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID08057717559668
NIH Device Record Key87151701-453a-4347-9f69-06e58220d03a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSILKTOE INSTRUMENT
Version Model Number50 Left Silktoe Trial Sizer (Red)
Catalog NumberBRDNPTEST50L
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

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.

Device Identifiers

Device Issuing AgencyDevice ID
GS108057717559668 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08057717559668]

Moist Heat or Steam Sterilization

[08057717559668]

Moist Heat or Steam Sterilization

[08057717559668]

Moist Heat or Steam Sterilization

[08057717559668]

Moist Heat or Steam Sterilization

[08057717559668]

Moist Heat or Steam Sterilization

[08057717559668]

Moist Heat or Steam Sterilization

[08057717559668]

Moist Heat or Steam Sterilization

[08057717559668]

Moist Heat or Steam Sterilization

[08057717559668]

Moist Heat or Steam Sterilization

[08057717559668]

Moist Heat or Steam Sterilization

[08057717559668]

Moist Heat or Steam Sterilization

[08057717559668]

Moist Heat or Steam Sterilization

[08057717559668]

Moist Heat or Steam Sterilization

[08057717559668]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-18
Device Publish Date2025-07-10

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
0805771755966850 Left Silktoe Trial Sizer (Red)
0805771755963735 Right Silktoe Trial Sizer (Yellow)
0805771755962035 Left Silktoe Trial Sizer (Yellow)
0805771755961330 Right Silktoe Trial Sizer (Orange)
0805771755960630 Left Silktoe Trial Sizer (Orange)
0805771755959020 Right Silktoe Trial Sizer (Green)
0805771755958320 Left Silktoe Trial Sizer (Green)
08057717559552Silktoe 40-50 Cutting Guide
08057717559521Silktoe 20-30 Metatarsal Quick Rasp
08057717559514Silktoe 20-30 Phalangeal Quick Rasp
08057717559507Silktoe 35 Metatarsal Quick Rasp
08057717559491Silktoe 40-50 Metatarsal Quick Rasp
08057717559484Silktoe 35 Phalangeal Quick Rasp
08057717559477Silktoe 40-50 Phalangeal Quick Rasp
08057717559460Silktoe 20-30 Metatarsal Grommet Quick Impactor
08057717559453Silktoe 35 Metatarsal Grommet Quick Impactor
08057717559446Silktoe 40-50 Metatarsal Grommet Quick Impactor
08057717559439Silktoe 20-30 Phalangeal Grommet Quick Impactor
08057717559422Silktoe 35 Phalangeal Grommet Quick Impactor
08057717559415Silktoe 40-50 Phalangeal Grommet Quick Impactor
08057717559392Quick Adapter type-C
08057717559385Silktoe Sterilization Quick Tray
08057717551303Silktoe Sterilization tray
08057717551273Silktoe Handle Sliding Unit
08053782780327Silktoe Cutting Guide holder
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.