| Primary Device ID | 00858325005442 |
| NIH Device Record Key | bf5578ef-4ed6-4ffb-a99f-220927df24bb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gauthier Biomedical |
| Version Model Number | 5161-00-5002 (G908145) |
| Catalog Number | 5161005002 |
| Company DUNS | 015227072 |
| Company Name | GAUTHIER BIOMEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1-262-546-0010 |
| xx@xx.com | |
| Phone | +1-262-546-0010 |
| xx@xx.com | |
| Phone | +1-262-546-0010 |
| xx@xx.com | |
| Phone | +1-262-546-0010 |
| xx@xx.com | |
| Phone | +1-262-546-0010 |
| xx@xx.com | |
| Phone | +1-262-546-0010 |
| xx@xx.com | |
| Phone | +1-262-546-0010 |
| xx@xx.com | |
| Phone | +1-262-546-0010 |
| xx@xx.com | |
| Phone | +1-262-546-0010 |
| xx@xx.com | |
| Phone | +1-262-546-0010 |
| xx@xx.com | |
| Phone | +1-262-546-0010 |
| xx@xx.com | |
| Phone | +1-262-546-0010 |
| xx@xx.com | |
| Phone | +1-262-546-0010 |
| xx@xx.com | |
| Phone | +1-262-546-0010 |
| xx@xx.com | |
| Phone | +1-262-546-0010 |
| xx@xx.com | |
| Phone | +1-262-546-0010 |
| xx@xx.com | |
| Phone | +1-262-546-0010 |
| xx@xx.com | |
| Phone | +1-262-546-0010 |
| xx@xx.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858325005442 [Primary] |
| HXB | Probe |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00858325005442]
Moist Heat or Steam Sterilization
[00858325005442]
Moist Heat or Steam Sterilization
[00858325005442]
Moist Heat or Steam Sterilization
[00858325005442]
Moist Heat or Steam Sterilization
[00858325005442]
Moist Heat or Steam Sterilization
[00858325005442]
Moist Heat or Steam Sterilization
[00858325005442]
Moist Heat or Steam Sterilization
[00858325005442]
Moist Heat or Steam Sterilization
[00858325005442]
Moist Heat or Steam Sterilization
[00858325005442]
Moist Heat or Steam Sterilization
[00858325005442]
Moist Heat or Steam Sterilization
[00858325005442]
Moist Heat or Steam Sterilization
[00858325005442]
Moist Heat or Steam Sterilization
[00858325005442]
Moist Heat or Steam Sterilization
[00858325005442]
Moist Heat or Steam Sterilization
[00858325005442]
Moist Heat or Steam Sterilization
[00858325005442]
Moist Heat or Steam Sterilization
[00858325005442]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-06 |
| Device Publish Date | 2023-11-28 |
| 00858325005084 | 1/4 inch (6,35mm) Square Secure Shaft Connector Extended Palm Torque Limiter Handle |
| 00858325005060 | This hand - held, orthopedic, manual, surgical instrument handle is designed to connect to shaft |
| 00858325005046 | AO Quick Connect Two Color Fixed Inline Handle |
| 00858325005039 | Tri-flat Quick Connect Fixed Inline Handle |
| 00858325005022 | Torque Limiter with Impact cap, Mini T-Handle |
| 00858325005015 | Multi-Color Ratcheting T-Handle |
| 00858325005008 | Multi-Color Inline Ratcheting Handle |
| 10858325005180 | Pack of Two G440350 Electronic Torque Indicator pencil grip, Fixed AO pull connect |
| 00858325005343 | 4-SIDED INLINE RATCHETING HANDLE 1/4 inch (6,35 mm) SQUARE SECURE SHAFT CONNECT (Distributor Par |
| 00858325005336 | Torque Limiter, 3 Nm, 7/32 inch (5,56 mm) Hex |
| 00858325005329 | Ratcheting T-Handle, Hybrid Hudson Connection |
| 00858325005312 | Inline Torque Adapter, Male Hall - Jacobs, 0.358 inch Hex Socket |
| 00858325005305 | Fixed Ultra Mini T-Handle 1/4 inch (6,35 mm) Square Connect |
| 00858325005282 | G10 Inline Handle Ratchet, 1 / 4 Inch (6,35 mm) Square, Reverse Impaction |
| 00858325005275 | G10 Palm Handle Ratchet, 1 / 4 Inch (6,35 mm) Square, Reverse Impaction |
| 00858325005244 | G10 T-Handle Ratchet, 1 / 4 Inch (6,35 mm) Square, Reverse Impaction |
| 00858325005237 | Offset T-Torque, 1 / 4 inch (6,35mm) Square, 12Nm |
| 00858325005220 | Balanced T-Torque, 1 / 4 inch (6,35mm) Square, 8Nm |
| 00858325005213 | Balanced T-Torque, 1 / 4 inch (6,35mm) Square, 12Nm |
| 00858325005206 | Inline Torque Adapter, Male Hudson/Zimmer with 1 / 4 inch (6,35 mm) Square Quick Connect |
| 00858325005190 | OSTEO CONTROL ™ ACCELERATED HANDLE |
| 00858325005176 | Fiber Tape (R) Cerclage Tensioner (Gauthier Part # G119852) |
| 00858325005169 | Low Torque T-Handle (Distributor Part Number 254600410) |
| 00858325005145 | Ratcheting Torque Limiting Allen Wrench |
| 00858325005114 | Ultra Mini Torque T- Handle with Tri-Flat Quick Connect |
| 00858325005107 | Ultra Mini Ratcheting Inline Handle with Tri-Flat Quick Connect |
| 00858325005091 | 1/4 inch (6,35mm) Square Connector Palm Style Ratcheting Handle |
| 00858325005077 | 4,75mm Square Fixed Ultra Mini T-Handle |
| 00858325005268 | Shaft, 1 / 4 inch (6,35mm) Square to 4mm Hex |
| 00858325005251 | Shaft, 1 / 4 inch (6,35mm) Square to 5mm Hex |
| 00858325005138 | Cervical Distractor for 3,2 - 3,5 mm rods |
| 00858325005121 | Cervical Compressor for 3,2 - 3,5 mm rods |
| 00858325005053 | Articulated Shaft Small AO T27 Torx tip |
| 00858325005374 | G10 LARGE INLINE RATCHETING HANDLE, SMALL HUDSON PULL COLLAR |
| 00858325005299 | G10 MINI INLINE RATCHETING HANDLE, AO PULL COLLAR |
| 00858325005367 | PALM HANDLE TORQUE LIMITER 1/4 inch (6,35mm) SQUARE SECURE SHAFT, 4Nm |
| 00858325005350 | Ultra Mini Torque T- Handle with Tri-Flat Quick Connect |
| 00858325005398 | INLINE TORQUE ADAPTER, HALL JACOBS SHAFT, 10mm HEX SOCKET, 35 in lbs 93,95 Nm) (Smith & Nephew |
| 00858325005381 | INLINE RATCHETING TORQUE LIMITER, 1/4 inch (6,35 mm) SQUARE CONNECT |
| 00858325005404 | BALANCED T-HANDLE TORQUE LIMITER, 1/4 inch (6,35 mm) SQUARE CONNECT |
| 00858325005497 | INLINE HANDLE, RATCHETING |
| 00858325005473 | PROBE, ILIAC STRAIGHT |
| 00858325005688 | TORQUE LIMITER, RATCHET 11.3NM |
| 00858325005671 | TORQUE LIMITER, 11.3NM |
| 00858325005558 | MINI INLINE HANDLE, RATCHETING |
| 00858325005503 | PALM HANDLE, RATCHETING |
| 00858325005480 | T HANDLE, RATCHETING |
| 00858325005541 | MINI INLINE HANDLE |
| 00858325005534 | PALM HANDLE |
| 00858325005527 | INLINE HANDLE |