Gauthier Biomedical G850000

GUDID 00858325005039

Tri-flat Quick Connect Fixed Inline Handle

GAUTHIER BIOMEDICAL, INC.

Surgical instrument handle, non-torque-limiting
Primary Device ID00858325005039
NIH Device Record Keyeb15b711-7297-46ec-a904-7f234fb1b593
Commercial Distribution StatusIn Commercial Distribution
Brand NameGauthier Biomedical
Version Model NumberG850000
Catalog NumberG850000
Company DUNS015227072
Company NameGAUTHIER BIOMEDICAL, INC.
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com
Phone262-546-0010
Emailxxxx@xxxx.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858325005039 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

[00858325005039]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-17
Device Publish Date2020-08-07

On-Brand Devices [Gauthier Biomedical]

008583250050841/4 inch (6,35mm) Square Secure Shaft Connector Extended Palm Torque Limiter Handle
00858325005060This hand - held, orthopedic, manual, surgical instrument handle is designed to connect to shaft
00858325005046AO Quick Connect Two Color Fixed Inline Handle
00858325005039Tri-flat Quick Connect Fixed Inline Handle
00858325005022Torque Limiter with Impact cap, Mini T-Handle
00858325005015Multi-Color Ratcheting T-Handle
00858325005008Multi-Color Inline Ratcheting Handle
10858325005180Pack of Two G440350 Electronic Torque Indicator pencil grip, Fixed AO pull connect
008583250053434-SIDED INLINE RATCHETING HANDLE 1/4 inch (6,35 mm) SQUARE SECURE SHAFT CONNECT (Distributor Par
00858325005336Torque Limiter, 3 Nm, 7/32 inch (5,56 mm) Hex
00858325005329Ratcheting T-Handle, Hybrid Hudson Connection
00858325005312Inline Torque Adapter, Male Hall - Jacobs, 0.358 inch Hex Socket
00858325005305Fixed Ultra Mini T-Handle 1/4 inch (6,35 mm) Square Connect
00858325005282G10 Inline Handle Ratchet, 1 / 4 Inch (6,35 mm) Square, Reverse Impaction
00858325005275G10 Palm Handle Ratchet, 1 / 4 Inch (6,35 mm) Square, Reverse Impaction
00858325005244G10 T-Handle Ratchet, 1 / 4 Inch (6,35 mm) Square, Reverse Impaction
00858325005237Offset T-Torque, 1 / 4 inch (6,35mm) Square, 12Nm
00858325005220Balanced T-Torque, 1 / 4 inch (6,35mm) Square, 8Nm
00858325005213Balanced T-Torque, 1 / 4 inch (6,35mm) Square, 12Nm
00858325005206Inline Torque Adapter, Male Hudson/Zimmer with 1 / 4 inch (6,35 mm) Square Quick Connect
00858325005190OSTEO CONTROL ™ ACCELERATED HANDLE
00858325005176Fiber Tape (R) Cerclage Tensioner (Gauthier Part # G119852)
00858325005169Low Torque T-Handle (Distributor Part Number 254600410)
00858325005145Ratcheting Torque Limiting Allen Wrench
00858325005114Ultra Mini Torque T- Handle with Tri-Flat Quick Connect
00858325005107Ultra Mini Ratcheting Inline Handle with Tri-Flat Quick Connect
008583250050911/4 inch (6,35mm) Square Connector Palm Style Ratcheting Handle
008583250050774,75mm Square Fixed Ultra Mini T-Handle
00858325005268Shaft, 1 / 4 inch (6,35mm) Square to 4mm Hex
00858325005251Shaft, 1 / 4 inch (6,35mm) Square to 5mm Hex
00858325005138Cervical Distractor for 3,2 - 3,5 mm rods
00858325005121Cervical Compressor for 3,2 - 3,5 mm rods
00858325005053Articulated Shaft Small AO T27 Torx tip
00858325005374G10 LARGE INLINE RATCHETING HANDLE, SMALL HUDSON PULL COLLAR
00858325005299G10 MINI INLINE RATCHETING HANDLE, AO PULL COLLAR
00858325005367PALM HANDLE TORQUE LIMITER 1/4 inch (6,35mm) SQUARE SECURE SHAFT, 4Nm
00858325005350Ultra Mini Torque T- Handle with Tri-Flat Quick Connect
00858325005398INLINE TORQUE ADAPTER, HALL JACOBS SHAFT, 10mm HEX SOCKET, 35 in lbs 93,95 Nm) (Smith & Nephew
00858325005381INLINE RATCHETING TORQUE LIMITER, 1/4 inch (6,35 mm) SQUARE CONNECT
00858325005404BALANCED T-HANDLE TORQUE LIMITER, 1/4 inch (6,35 mm) SQUARE CONNECT
00858325005497INLINE HANDLE, RATCHETING
00858325005473PROBE, ILIAC STRAIGHT
00858325005688TORQUE LIMITER, RATCHET 11.3NM
00858325005671TORQUE LIMITER, 11.3NM
00858325005558MINI INLINE HANDLE, RATCHETING
00858325005503PALM HANDLE, RATCHETING
00858325005480T HANDLE, RATCHETING
00858325005541MINI INLINE HANDLE
00858325005534PALM HANDLE
00858325005527INLINE HANDLE
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