| Primary Device ID | 00842102115097 |
| NIH Device Record Key | 5a065fb3-edd0-4db9-9d59-bfb1179c5140 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mediflex Universal Round Bar Table Mounted Retractor Systems |
| Version Model Number | 75136-B |
| Company DUNS | 047644935 |
| Company Name | FLEXBAR MACHINE CORPORATION |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842102115097 [Primary] |
| FFO | Retractor, Self-Retaining |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00842102115097]
Moist Heat or Steam Sterilization
[00842102115097]
Moist Heat or Steam Sterilization
[00842102115097]
Moist Heat or Steam Sterilization
[00842102115097]
Moist Heat or Steam Sterilization
[00842102115097]
Moist Heat or Steam Sterilization
[00842102115097]
Moist Heat or Steam Sterilization
[00842102115097]
Moist Heat or Steam Sterilization
[00842102115097]
Moist Heat or Steam Sterilization
[00842102115097]
Moist Heat or Steam Sterilization
[00842102115097]
Moist Heat or Steam Sterilization
[00842102115097]
Moist Heat or Steam Sterilization
[00842102115097]
Moist Heat or Steam Sterilization
[00842102115097]
Moist Heat or Steam Sterilization
[00842102115097]
Moist Heat or Steam Sterilization
[00842102115097]
Moist Heat or Steam Sterilization
[00842102115097]
Moist Heat or Steam Sterilization
[00842102115097]
Moist Heat or Steam Sterilization
[00842102115097]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-07 |
| Device Publish Date | 2022-10-28 |
| 00842102113062 | Blade, Sternal, Swivel, 3" x 3" (7.5 x 7.5cm) w/ 10" |
| 00842102113055 | Blade, Sternal, Swivel, 3" x 3" (7.5 x 7.5cm) |
| 00842102112850 | Universal TMR Angled Lateral Arm 11x13" (27.9x33cm) 1/2" (1.3cm) Diameter |
| 00842102112843 | Universal TMR Angled Lateral Arm 8x10" (20.3x24.6cm) 1/2" (1.3cm) Diameter |
| 00842102109898 | Malleable Slotted Swivel Retractor, 3" x 6-1/2" (7.3cm x 16.5cm) |
| 00842102109881 | Renal Vein Swivel Retractor, 1" x 6" (2.5cm - 15.2 cm) |
| 00842102109874 | Splanchnic Swivel Retractor, 2" x 4 1/2" (5cm x 11.4cm) |
| 00842102109867 | Malleable Slotted Swivel Retractor, 2" x 6-1/2" (5cm x 16.5cm) |
| 00842102109850 | Marshall Bladder Malleable Swivel Retractor, 3" x 6" |
| 00842102109843 | Harrington Swetheart Swivel Retractor, 2" x5" (5cm x 12.7cm) |
| 00842102109836 | Fence swivel retractor, 4" x 6" (10cm x 15.2cm) |
| 00842102109829 | Splanchnic Swivel Retractor,2' x 6' (5cm x 15.2cm) |
| 00842102109812 | Univ. TMR Blade, Splanchnic Aluminum, 4 x 5 3/4" (10.2cm x 14.6cm) |
| 00842102109805 | Univ. TMR Blade,Deaver 6 x 15cm |
| 00842102109799 | Univ. TMR Blade, Deaver Aluminum, 2 3/4 x 4 1/2" (7.0 x 11.4cm) |
| 00842102109782 | Flex-Light Fiber Optic Light Pipe Clip (for Univ. TMR Systems) |
| 00842102109775 | Univ.TMR Blade Malleable 1/2" x 4"(Use#72110-R) |
| 00842102109768 | 18" Field Post with Two Stop Collars |
| 00842102109751 | Univ TMR Small Incision Starter Sys.1,no Blades |
| 00842102109744 | Universal Retractor Frame for Detachable Arms |
| 00842102109737 | Universal Frame with Clasper Bar, for Interchangeable Arms |
| 00842102109720 | Long & Short Arm Set for Universal Frame |
| 00842102109713 | Univ TMR snap on retractor blade clamp |
| 00842102109706 | Univ. TMR Blade, Meyerding, 2 x 3" (5.1 x 7.6cm) |
| 00842102109690 | Malleable Retractor Blade 1"x 4" w/o protective edge |
| 00842102109683 | Univ. TMR Blade, Splanchnic, 4 x 7" (10.2 x 17.8cm) |
| 00842102109676 | Univ. TMR,Basic Sys. w/4 Clamps,No Blades |
| 00842102109669 | Universal Retractor,Complete System |
| 00842102109652 | Univ. TMR Blade, Harrington, Alum, 2 5/8 x 5 5/8 x 3 1/2" (6.7 x 14.3 x 8.9cm) |
| 00842102109645 | Univ. TMR Blade, Splanchnic, Aluminum, 1 1/2 x 6" (3.8 x 15.2cm) |
| 00842102109638 | Univ. TMR Blade, Splanchnic, Aluminum, 2 x 6" (5.1 x 15.2cm) |
| 00842102109621 | Univ. TMR Blade, Splanchnic Alum, 2 x 4 1/2" (5.1 x 11.4) |
| 00842102109614 | Univ. TMR Blade, Wylie Renal Vein, Aluminum, 1 x 8" (2.5 x 20.3cm) |
| 00842102109607 | Univ. TMR Blade, Wylie Renal Vein, Aluminum, 1 x 4" (2.5 x 10.2cm) |
| 00842102109591 | Univ. TMR Blade, Balfour Mayo, Aluminum, 3 1/2 x 2" (8.9 x 5.1cm) |
| 00842102109584 | Univ. TMR Blade, Malleable, Aluminum, 3 x 6 1/2" (7.6 x 16.5cm) |
| 00842102109577 | Univ. TMR Blade, Malleable, Aluminum, 2 x 6 1/2" (5.1 x 16.5cm) |
| 00842102109560 | Univ. TMR Blade, Wylie Renal Vein, Aluminum, 1 x 6" (2.5 x 10.2cm) |
| 00842102109553 | Univ. TMR Blade, Wylie Renal Vein, Malleable Aluminum, 1 x 4" |
| 00842102109546 | Univ. TMR Blade, Balfour Mayo, 3 1/2 x 3 7/8" (8.9 x 9.8cm) |
| 00842102109539 | Univ. TMR Blade, Balfour Mayo, 3 1/2 x 3 1/8" (8.9 x 7.9cm) |
| 00842102109522 | Univ. TMR Blade, Balfour Mayo, 3 1/2 x 2 3/8" (8.9 x 6.0cm) |
| 00842102109515 | Univ. TMR Blade, Splanchnic, 4 x 8" (10.2 x 20.3cm) |
| 00842102109508 | Univ. TMR Blade, Splanchnic, 4 x 5 3/4" (10.2cm x 14.6cm) |
| 00842102109492 | Univ. TMR Blade, Splanchnic, 3 x 6 1/4" (7.6 x 15.9cm) |
| 00842102109485 | Univ. TMR Blade, Splanchnic, 3 x 5" (7.6 x 12.7cm) |
| 00842102109478 | Univ. TMR Blade, Splanchnic, Aluminum, 2 3/8 x 8 3/8" (6.0 x 21.3cm) |
| 00842102109461 | Univ. TMR Blade, Splanchnic, 2 3/8 x 8 3/8" (6.0 x 21.3cm) |
| 00842102109454 | Univ. TMR Blade, Splanchnic, 2 1/4 x 7 3/4" (5.7 x 19.7cm) |
| 00842102109447 | Univ. TMR Blade, Splanchnic, 2 1/4 x 5 1/2" (5.7 x 14.0cm) |