Omni-Tract®
Omni-Tract® Omni-Access Sterile Field Post, 3/4in (1.9cm) Clamp with Universal Denver Maquet Jaw
3manufacturers in China registered for this device type
252catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (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 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
Record
| Listed by | Integra Lifesciences Corporation, United States |
|---|---|
| FDA product code | FGN |
| Device type | Retractor, Non-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 | 2018-02-23 |
| Record revised | 2026-03-02 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Width 4.4 cm; length 7.6 cm; width 1.75 in; length 3 in |
| Distribution end date | 2023-12-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11305R | In distribution | |
| 4957 | In distribution | |
| 3133 | 2.75in x 3in (7.0cm x 7.6cm) | In distribution |
| 3854R | In distribution | |
| 3533 | 3in x 8in (7.6cm x 20.3cm) | In distribution |
| 3981 | In distribution | |
| 11518 | In distribution | |
| 3796 | 2-1/2in x 7in (6.4 cm x 17.8 cm) | In distribution |
| 3917 | In distribution | |
| 11321 | In distribution | |
| 11355P | In distribution | |
| 3398 | 2in x 5in (5.1cm x 12.7cm) | In distribution |
| 3485 | 2-3/4in x 2in (7.0cm x 5.1cm) | In distribution |
| 4931 | In distribution | |
| 3185 | 1in x 5in (2.5cm x 12.7cm) | In distribution |
| 11515 | In distribution | |
| 3974P | In distribution | |
| 4985P | In distribution | |
| 3069P | In distribution | |
| 10707 | In distribution | |
| 3220 | 1.5in x 1.5in (3.8cm x 3.8cm) | In distribution |
| 3858RP | In distribution | |
| 11863 | In distribution | |
| 3900 | In distribution | |
| 4970P | In distribution | |
| 3796P | In distribution | |
| 3147R | 3″ Height | In distribution |
| 3919P | In distribution | |
| 10388P | In distribution | |
| 3104RP | In distribution | |
| 3858R | Width 4.4 cm | In distribution |
| 3908R | In distribution | |
| 11861 | In distribution | |
| 3976 | In distribution | |
| 4940 | In distribution | |
| FLEXGEN1 | In distribution | |
| 3201P | In distribution | |
| 3914 | In distribution | |
| 4596RP | In distribution | |
| 3977P | In distribution | |
| 3911P | In distribution | |
| 4929 | In distribution | |
| 11632 | In distribution | |
| 3397RP | In distribution | |
| 11637P | In distribution | |
| 11360P | In distribution | |
| 3222R | 4.50″ Length x 2.75″ Height | In distribution |
| 11641 | In distribution | |
| 3814P | In distribution | |
| 4958 | In distribution | |
| 3216 | 1in x 4.5in (2.5cm x 11.4cm) | In distribution |
| 3602 | 4.0″ Length x 3.15″ Width x 1.5″ Height | In distribution |
| 3132RP | In distribution | |
| 11121 | In distribution | |
| 4605P | In distribution | |
| 3842 | In distribution | |
| 11402P | In distribution | |
| 4968P | In distribution | |
| 3759 | 8in x 18in (20.3cm x 45.7cm) | In distribution |
| 3631 | In distribution | |
| 3605P | In distribution | |
| 4621P | In distribution | |
| 3765P | In distribution | |
| 3091RP | In distribution | |
| 3921P | In distribution | |
| 3534 | 4in x 8in (10.2cm x 20.3cm) | In distribution |
| 3274P | In distribution | |
| 4935P | In distribution | |
| 3878R | In distribution | |
| 4954 | In distribution | |
| 11405R | In distribution | |
| 3046R | 6in (15.2cm) | In distribution |
| 3555 | .75in x.50in (1.9cm x 1.3cm) | In distribution |
| 11908P | In distribution | |
| 3132R | 2″ Length x 2.75″ Height | In distribution |
| 3979P | In distribution | |
| 11070 | In distribution | |
| 3603 | 2.0″ Length x 1.785″ Width x 0.75″ Height | In distribution |
| 3536 | 3.5in x 2.75in (8.9cm x 7.0cm) | In distribution |
| 3798P | In distribution | |
| 3595 | In distribution | |
| 3806RP | In distribution | |
| 3343 | 1in x 2in (2.5cm x 5.1cm) | In distribution |
| 3605 | 4.0″ Length x 1.785″ Width x 0.75″ Height | In distribution |
| 4963P | In distribution | |
| 11443 | In distribution | |
| 3086 | 20.00″ Length x 0.5000″ Diameter | In distribution |
| 3586 | In distribution | |
| 3092 | 4-1/4in x 3in (10.8cm x 7.6cm) | In distribution |
| 3530P | In distribution | |
| 3784 | 2-3/4in x 4-1/2in (7.0cm x 11.4cm) | In distribution |
| 11864 | In distribution | |
| 11407P | In distribution | |
| 4070 | In distribution | |
| 11383P | In distribution | |
| 11818 | In distribution | |
| 3259R | 0.875″ Height | In distribution |
| 3377R | 7.0″ Length x 1.323″ Width x 1.50″ Height | In distribution |
| 3529P | In distribution | |
| 4090 | In distribution | |
| 4964 | In distribution | |
| 4963 | In distribution | |
| 11500 | In distribution | |
| 11447 | In distribution | |
| 11481P | In distribution | |
| 11512 | In distribution | |
| 4597 | In distribution | |
| 4596R | In distribution | |
| 3152RP | In distribution | |
| FLEXVAS1 | In distribution | |
| 3596 | 5″ Length x 2.00″ Height | In distribution |
| 3872P | In distribution | |
| 3784P | In distribution | |
| 4594P | In distribution | |
| 3575P | In distribution | |
| 3265R | 1.5″ Height | In distribution |
| 3883R | In distribution | |
| 3101R | 1″ Height | In distribution |
| 11822 | In distribution | |
| 3187R | 2.00″ Height | In distribution |
| 11840P | In distribution | |
| 3909 | In distribution | |
| 3483 | 2in x 2in (5.1cm x 5.1cm) | In distribution |
| 3312P | In distribution | |
| 3614P | In distribution | |
| 3790P | In distribution | |
| 3790 | 3in x 6-1/2in (7.6cm x 16.5cm) | In distribution |
| 11640 | In distribution | |
| 11400RP | In distribution | |
| 4593 | In distribution | |
| 3218P | In distribution | |
| STGEN1 | In distribution | |
| 11385 | In distribution | |
| 11932 | In distribution | |
| 11860 | In distribution | |
| 3096 | 2-3/4in x 2in (7.0cm x 5.1cm) | In distribution |
| 3623P | In distribution | |
| 4605 | In distribution | |
| 3086 | 20.00″ Length x 0.5000″ Diameter | In distribution |
| 4604 | In distribution | |
| 11640P | In distribution | |
| 3532P | In distribution | |
| 3804R | 3.125″ Width x 1.50″ Height | In distribution |
| 11440 | In distribution | |
| 3786 | 1in x 4in (2.5cm x 10.2cm) | In distribution |
| 3203P | In distribution | |
| 3393RP | In distribution | |
| 3424 | 12in x 18in (30.5cm x 45.7cm) | In distribution |
| 3926P | In distribution | |
| 11642 | In distribution | |
| 11443P | In distribution | |
| 3529 | 2in x 8in (5.1cm x 20.3cm) | In distribution |
| 10385P | In distribution | |
| 3225RP | In distribution | |
| 11789P | In distribution | |
| 10244 | In distribution | |
| 3032 | 7/16in (1.1cm) | In distribution |
| 3032P | In distribution | |
| 11641P | In distribution | |
| 11401R | In distribution | |
| 11933P | In distribution | |
| 11865 | In distribution | |
| 3535 | 8″ Length x 4″ Height | In distribution |
| 4615R | In distribution | |
| 3053R | In distribution | |
| 3311RP | In distribution | |
| 4080P | In distribution | |
| 11309 | In distribution | |
| 10387P | In distribution | |
| 3808RP | In distribution | |
| 11644 | In distribution | |
| 4970 | In distribution | |
| 3148 | 3in x 4-1/2in (7.6cm x 11.4cm) | In distribution |
| 11511P | In distribution | |
| 11938 | In distribution | |
| 3906RP | In distribution | |
| 3604 | 3.0″ Length x 1.785″ Width x 0.75″ Height | In distribution |
| 4975P | In distribution | |
| 11517P | In distribution | |
| 4981 | In distribution | |
| 11402 | In distribution | |
| 3137 | In distribution | |
| 3804RP | In distribution | |
| 11639 | In distribution | |
| 4599 | In distribution | |
| 11309P | In distribution | |
| 3279R | 1″ Height | In distribution |
| 11900 | In distribution | |
| 3931 | In distribution | |
| 3177P | In distribution | |
| 10272 | Strap-27″ Length | In distribution |
| 3532 | 2in x 8in (5.1cm x 20.3cm) | In distribution |
| 3091R | 9″ Length x 5.5″ Wide | In distribution |
| 3918P | In distribution | |
| 4600P | In distribution | |
| 3975P | In distribution | |
| 3740P | In distribution | |
| 11632P | In distribution | |
| 4931P | In distribution | |
| 4929P | In distribution | |
| 11383 | In distribution | |
| 11866P | In distribution | |
| 11401RP | In distribution | |
| 3932P | In distribution | |
| 3914P | In distribution | |
| 3222RP | In distribution | |
| 3816 | In distribution | |
| 11629 | In distribution | |
| 3982RP | In distribution | |
| 11910 | In distribution | |
| 4959P | In distribution | |
| 3620 | 2in x 1-1/2in (5.1cm x 3.8cm) | In distribution |
| 3624 | 6in (15.2cm) | In distribution |
| 4980 | In distribution | |
| 11902 | In distribution | |
| 3623 | 9in (22.9cm) | In distribution |
| 3185P | In distribution | |
| 4958P | In distribution | |
| 4080 | In distribution | |
| 4571P | In distribution | |
| 3093 | 5in x 3-1/2in (12.7cm x 8.9cm) | In distribution |
| 3592 | 2in x 6-1/2in (5.1cm x 16.5cm) | In distribution |
| 3892 | In distribution | |
| 4020 | In distribution | |
| 11502RP | In distribution | |
| 3732P | In distribution | |
| 11902P | In distribution | |
| 3096P | In distribution | |
| 3138RP | In distribution | |
| 3281RP | In distribution | |
| 11925P | In distribution | |
| 10270P | In distribution | |
| 3147RP | In distribution | |
| 3145R | 3″ Height | In distribution |
| 10709P | In distribution | |
| 3142 | 3.5in x 2.75in (8.9cm x 7.0cm) | In distribution |
| 3886P | In distribution | |
| 11300RP | In distribution | |
| 4600 | In distribution | |
| 3814 | In distribution | |
| 4921 | In distribution | |
| 11631P | In distribution | |
| 3927P | In distribution | |
| 4966P | In distribution | |
| 3536P | In distribution | |
| 4950P | In distribution | |
| 3422R | 26.63″ Length x 12.63″ Width x 4.63 Height | In distribution |
| 11964P | In distribution | |
| 3151R | 6.5″ Length x 3.00″ Width | In distribution |
| 11404R | In distribution |
Showing 250 of 252 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 408 |
| Orthomed | Ortho-MED, Inc. | 205 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 47 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 26 |
| V. Mueller | Steris Corporation | 24 |
| Novo Surgical | Novo Surgical, Inc. | 24 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 18 |
| Ambler Surgical | Ambler Surgical, LLC | 16 |
| Tebbetts Suction Wound Retractor | Sontec Instruments, Inc. | 12 |
| Cochran Pediatric Retractor | Sontec Instruments, Inc. | 10 |
| Pilling | Teleflex Medical LLC | 10 |
| Hill-Ferguson Retractor | Sontec Instruments, Inc. | 8 |
Showing 12 of 51. All products under Retractor, Non-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.