Omni-Tract®
Omni-Tract® Mayo Wide, Deep Swivel Blade with 3/8in (1.0cm) Hole, 3.5in x 4in (8.9cm x 10.2cm)
3manufacturers in China registered for this device type
347catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
Record
| Listed by | Integra Lifesciences Corporation, United States |
|---|---|
| FDA product code | FFO |
| Device type | Retractor, Self-Retaining |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-04-19 |
| Record revised | 2023-05-15 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Length 7 to 14 cm; width 0.75 to 4 in; width 1.9 to 10.2 cm; length 2.75 to 5.5 in |
| Distribution end date | 2023-12-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FASTGEN1 | In distribution | |
| 4606 | In distribution | |
| 3374RP | In distribution | |
| 11560 | In distribution | |
| 3259RP | In distribution | |
| 11490P | In distribution | |
| 3931P | In distribution | |
| 3374R | 4.0″ Length x 1.323″ Width x 1.50″ Height | In distribution |
| 11119 | In distribution | |
| 4606P | In distribution | |
| 11964 | 1in x 4.5in (2.5cm x 11.4cm) | In distribution |
| 3105RP | In distribution | |
| 3800P | In distribution | |
| 4602P | In distribution | |
| 3929 | In distribution | |
| 11637 | In distribution | |
| 3575 | In distribution | |
| 3216P | In distribution | |
| 3908RP | In distribution | |
| 3201 | 2in x 4-1/2in (5.1cm x 11.4cm) | In distribution |
| 11628P | In distribution | |
| 3909P | In distribution | |
| 11305RP | In distribution | |
| 4973P | In distribution | |
| 3761P | In distribution | |
| 4932P | In distribution | |
| 11633P | In distribution | |
| 3976P | In distribution | |
| 11121P | In distribution | |
| 3586P | In distribution | |
| 10386P | In distribution | |
| 4927P | In distribution | |
| 11030P | In distribution | |
| 3375R | 5.0″ Length x 1.323″ Width x 1.50″ Height | In distribution |
| 3594P | In distribution | |
| 11944 | In distribution | |
| 11514P | In distribution | |
| 4972P | In distribution | |
| 11615P | In distribution | |
| 11645 | In distribution | |
| 3103RP | In distribution | |
| 3635P | In distribution | |
| 3150R | 6.5″ Length x 2.00″ Width | In distribution |
| 3975 | In distribution | |
| 11050P | In distribution | |
| 3922P | In distribution | |
| 3818R | In distribution | |
| 11840 | In distribution | |
| 11835 | In distribution | |
| 11635 | In distribution | |
| 3626 | In distribution | |
| 3888 | In distribution | |
| 11407 | In distribution | |
| 11950P | In distribution | |
| 11780 | In distribution | |
| 11933 | In distribution | |
| 3092P | In distribution | |
| 3094R | 3.00″ Width x 3″ Height | In distribution |
| 4607 | In distribution | |
| 3622P | In distribution | |
| 3557 | .375in (1.0cm) | In distribution |
| 11404RP | In distribution | |
| 11944P | In distribution | |
| 11627P | In distribution | |
| 3335 | 2-3/4in x 2in (7.0cm x 5.1cm) | In distribution |
| 3105R | 1″ Height | In distribution |
| 3977 | In distribution | |
| 3379RP | In distribution | |
| 4956 | In distribution | |
| 4601P | In distribution | |
| 4019P | In distribution | |
| 4602 | In distribution | |
| 4960 | In distribution | |
| 11448 | In distribution | |
| 3732 | In distribution | |
| 3373RP | In distribution | |
| 3176 | 4″ Length x 3.5″ Height | In distribution |
| 4937 | In distribution | |
| 3860 | In distribution | |
| 3101RP | In distribution | |
| 3281R | 0.875″ Height | In distribution |
| 11635P | In distribution | |
| 3926 | In distribution | |
| 3792 | 3in x 6in (7.6cm x 15.2cm) | In distribution |
| 3041RP | In distribution | |
| 3177 | In distribution | |
| 3868RP | In distribution | |
| 11405RP | In distribution | |
| 3917P | In distribution | |
| 4933P | In distribution | |
| 11301RP | In distribution | |
| 3394RP | In distribution | |
| 11942 | In distribution | |
| 3878RP | In distribution | |
| 3876RP | In distribution | |
| 3854RP | In distribution | |
| 3398P | In distribution | |
| 3618 | 1/2in x 1in (1.3cm x 2.5cm) | In distribution |
| 4962P | In distribution | |
| 3907R | In distribution | |
| 11880 | In distribution | |
| 3341RP | In distribution | |
| 11910P | In distribution | |
| 3265RP | In distribution | |
| 11570 | In distribution | |
| 11590 | In distribution | |
| 4972 | In distribution | |
| 3602P | In distribution | |
| 11409 | In distribution | |
| 3041R | 3/8in (1.0cm) | In distribution |
| 3720 | In distribution | |
| 11950 | In distribution | |
| 3424P | In distribution | |
| 11646P | In distribution | |
| 4964P | In distribution | |
| 4595P | In distribution | |
| 3872 | In distribution | |
| 11352 | In distribution | |
| 11952 | In distribution | |
| 3980 | In distribution | |
| 3374R | 4.0″ Length x 1.323″ Width x 1.50″ Height | In distribution |
| 11940P | In distribution | |
| 10487 | In distribution | |
| 4981P | In distribution | |
| 3343P | In distribution | |
| 3979 | In distribution | |
| 11560P | In distribution | |
| 11633 | In distribution | |
| 3630P | In distribution | |
| 11875P | In distribution | |
| 11868P | In distribution | |
| 3094RP | In distribution | |
| 11400R | In distribution | |
| 3812 | In distribution | |
| 11183 | 27″ Length | In distribution |
| 11501P | In distribution | |
| 3152R | 6.5″ Length x 4.00″ Width | In distribution |
| 3906R | In distribution | |
| 11861P | In distribution | |
| 4961P | In distribution | |
| 10493P | In distribution | |
| 4599P | In distribution | |
| 11308P | In distribution | |
| 3103R | 1in x 1in (2.5cm x 2.5cm) | In distribution |
| 4980P | In distribution | |
| 3928 | In distribution | |
| 4105RP | In distribution | |
| 4973 | In distribution | |
| 3788 | 2in x 6-1/2in (5.1cm x 16.5cm) | In distribution |
| 3974 | In distribution | |
| 11788 | In distribution | |
| 4040P | In distribution | |
| 3810R | Length 10.2 cm | In distribution |
| 3093P | In distribution | |
| 4985 | In distribution | |
| 11441 | In distribution | |
| 11946P | In distribution | |
| 3342P | In distribution | |
| 4607P | In distribution | |
| 3046RP | In distribution | |
| 11440P | In distribution | |
| 3422RP | In distribution | |
| 4937P | In distribution | |
| 3635 | In distribution | |
| 11306P | In distribution | |
| 11384 | In distribution | |
| 3530 | 1in x 8in (2.5cm x 20.3cm) | In distribution |
| 3774P | In distribution | |
| 3892P | In distribution | |
| 11865P | In distribution | |
| 3373R | 3.0″ Length x 1.323″ Width x 1.50″ Height | In distribution |
| 11615 | In distribution | |
| 3923 | In distribution | |
| 11501 | In distribution | |
| 11936 | In distribution | |
| 11355 | In distribution | |
| 3631P | In distribution | |
| 3121R | Length 5.5 in | In distribution |
| 4974P | In distribution | |
| 11275P | In distribution | |
| 10385 | In distribution | |
| 3923P | In distribution | |
| 10272P | In distribution | |
| 10498P | In distribution | |
| 3983 | In distribution | |
| 3782P | In distribution | |
| 3620P | In distribution | |
| 3822R | In distribution | |
| 11610R | In distribution | |
| 4940P | In distribution | |
| 11627 | In distribution | |
| 11820P | In distribution | |
| 3335P | In distribution | |
| 4976 | In distribution | |
| 11442P | In distribution | |
| 3279RP | In distribution | |
| 4954P | In distribution | |
| 11444P | In distribution | |
| 3030R | 23.5″ Length x 0.625″ Diameter | In distribution |
| 3588P | In distribution | |
| 11570P | In distribution | |
| 3217 | 1in x 6in (2.5cm x 15.2cm) | In distribution |
| 4976P | In distribution | |
| 3531 | 2-3/4in x 8in (7.0cm x 20.3cm) | In distribution |
| FEMUR1 | In distribution | |
| 11849P | In distribution | |
| 11820 | In distribution | |
| 11386 | In distribution | |
| 3393R | 6.0″ Length x 1.36″ Width x 1.00″ Height | In distribution |
| 4922 | In distribution | |
| 3624P | In distribution | |
| 10389 | In distribution | |
| 11645P | In distribution | |
| 3978P | In distribution | |
| 11610RP | In distribution | |
| 11932P | In distribution | |
| 4968 | In distribution | |
| 4944P | In distribution | |
| 3099P | In distribution | |
| 3888P | In distribution | |
| 10487P | In distribution | |
| 10389P | In distribution | |
| 3555P | In distribution | |
| 11500P | In distribution | |
| 3800 | 1-1/2in x 6in (3.8cm x 15.2cm) | In distribution |
| 4961 | In distribution | |
| 3537P | In distribution | |
| 10144RP | In distribution | |
| 3812P | In distribution | |
| 3882RP | In distribution | |
| 11931P | In distribution | |
| 10387 | In distribution | |
| 4957P | In distribution | |
| 4928P | In distribution | |
| 4956P | In distribution | |
| 3927 | In distribution | |
| 3932 | In distribution | |
| 3862P | In distribution | |
| 3915P | In distribution | |
| 11300R | In distribution | |
| 10390P | In distribution | |
| 3133P | In distribution | |
| 3907RP | In distribution | |
| 4621 | In distribution | |
| 3982R | In distribution | |
| 11050 | In distribution | |
| 3593 | 3in x 6-1/2in (7.6cm x 16.5cm) | In distribution |
| 11481 | In distribution | |
| 11510 | In distribution | |
| 11306 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 1,870 |
| Mediflex Universal Round Bar Table Mounted Retractor Systems | Flexbar Machine Corp. | 271 |
| Bookler Table Mounted Retractor Systems | Flexbar Machine Corp. | 209 |
| Sklar® | Sklar Corporation | 203 |
| Pilling | Teleflex Medical LLC | 184 |
| Hayden Medical | Hayden Medical Inc | 172 |
| V. Mueller | Steris Corporation | 158 |
| Ambler Surgical | Ambler Surgical, LLC | 118 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 115 |
| Aesculap | Aesculap AG | 107 |
| Mini-Bookler Table Mounted Retractor Systems | Flexbar Machine Corp. | 105 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 56 |
Showing 12 of 178. All products under Retractor, Self-Retaining
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Integra Lifesciences Corporation | UDI-DI | 2026-06-05 | Class II | Labeling design | The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle | 633 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.