Omni-Tract®
Omni-Tract® Harrington Sweetheart Swivel Blade with 3/8in (1.0cm) Hole, 2.5in x 7in (6.4cm x 17.8cm)
34manufacturers in China registered for this device type
310catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (7), Zhejiang (6). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
Showing 12 of 34. All 34 manufacturers in China registered for Retractor
Record
| Listed by | Integra Lifesciences Corporation, United States |
|---|---|
| FDA product code | GAD |
| Device type | Retractor |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-02-23 |
| Record revised | 2026-05-29 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2023-12-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11958 | In distribution | |
| 3924P | In distribution | |
| 3394R | 7.0″ Length x 1.36″ Width x 1.00″ Height | In distribution |
| 11321P | In distribution | |
| 3798 | 1-1/2in x 4in (3.8cm x 10.2cm) | In distribution |
| 11382P | In distribution | |
| 4547 | In distribution | |
| 3862 | In distribution | |
| 3980P | In distribution | |
| 11445 | In distribution | |
| 3925 | In distribution | |
| 11480P | In distribution | |
| 4967P | In distribution | |
| 11409P | In distribution | |
| 11940 | In distribution | |
| 3603 | 2.0″ Length x 1.785″ Width x 0.75″ Height | In distribution |
| 11628 | In distribution | |
| 3911 | In distribution | |
| 3379R | 6in (15.2cm) | In distribution |
| 11948P | In distribution | |
| 10388 | In distribution | |
| 3924 | In distribution | |
| 3392R | 5.0″ Length x 1.36″ Width x 1.00″ Height | In distribution |
| 3377RP | In distribution | |
| 3392RP | In distribution | |
| 3626P | In distribution | |
| 3597P | In distribution | |
| 3219 | 6.0″ Length x 2.00″ Height | In distribution |
| 11302R | In distribution | |
| 3640 | In distribution | |
| 3535P | In distribution | |
| 3588 | In distribution | |
| 11442 | In distribution | |
| 11864P | In distribution | |
| 3820RP | In distribution | |
| 11826P | In distribution | |
| 11441P | In distribution | |
| 3520 | .50in OD x Ø.07in (1.3cm OD x Ø.2cm) | In distribution |
| 11308 | In distribution | |
| 10708 | In distribution | |
| 4935 | In distribution | |
| 3772 | 4in x 6in (10.2cm x 15.2cm) | In distribution |
| 11948 | In distribution | |
| 3485P | In distribution | |
| 11968P | In distribution | |
| 4969P | In distribution | |
| 3167R | 0.75″ Height | In distribution |
| 4950 | Strap-27″, Wedge Holder 2.65″ Length x 1.000″ Width x 0.375″ Height | In distribution |
| 11502R | In distribution | |
| 11952P | In distribution | |
| 11301R | In distribution | |
| 4979 | In distribution | |
| 11848P | In distribution | |
| 11920P | In distribution | |
| 3146 | 3in x 3.5in (7.6cm x 8.9cm) | In distribution |
| 3848P | In distribution | |
| 3842P | In distribution | |
| 3765 | In distribution | |
| 3929P | In distribution | |
| 3720P | In distribution | |
| 11960P | In distribution | |
| 3397R | 3.5″ Height | In distribution |
| 4966 | In distribution | |
| 11360 | In distribution | |
| 3311R | In distribution | |
| 3203 | 1in x 4.5in (2.5cm x 11.4cm) | In distribution |
| 11119P | In distribution | |
| 11070P | In distribution | |
| 3874 | In distribution | |
| 11956P | In distribution | |
| 3531P | In distribution | |
| 3794 | 2in x 5in (5.1cm x 12.7cm) | In distribution |
| 4962 | In distribution | |
| 3120R | 3″ Height | In distribution |
| 11867P | In distribution | |
| 4017 | In distribution | |
| 3860P | In distribution | |
| 3593P | In distribution | |
| 3618P | In distribution | |
| 3916P | In distribution | |
| 4040 | In distribution | |
| 11446P | In distribution | |
| 3098 | 4in x 6in (10.2cm x 15.2cm) | In distribution |
| 3597 | 7″ Length x 2.50″ Height | In distribution |
| 10144R | In distribution | |
| 3146P | In distribution | |
| 4969 | In distribution | |
| 3223R | 8.125″ Length x 4″ Height | In distribution |
| 11275 | In distribution | |
| 11184P | In distribution | |
| 3824P | In distribution | |
| 3842 | In distribution | |
| 4595 | In distribution | |
| 3610 | In distribution | |
| 3792P | In distribution | |
| 4943 | In distribution | |
| 11510P | In distribution | |
| 4988 | In distribution | |
| 3818RP | In distribution | |
| 11867 | In distribution | |
| 3886 | In distribution | |
| 3055P | In distribution | |
| 3925P | In distribution | |
| 3361RP | In distribution | |
| 10390 | In distribution | |
| 3601 | 6.0″ Length x 3.15″ Width x 1.5″ Height | In distribution |
| 3927 | In distribution | |
| 3590 | 1-1/2in x 3-1/2in (3.8cm x 8.9cm) | In distribution |
| 5280P | In distribution | |
| 3376R | 6.0″ Length x 1.323″ Width x 1.50″ Height | In distribution |
| 3178RP | In distribution | |
| 4020P | In distribution | |
| 3076 | In distribution | |
| 3880RP | In distribution | |
| 10244P | In distribution | |
| 3169RP | In distribution | |
| 11830P | In distribution | |
| 10270 | In distribution | |
| 11789 | In distribution | |
| 3856RP | In distribution | |
| 4622 | In distribution | |
| 10405R | In distribution | |
| 11403RP | In distribution | |
| 11821P | In distribution | |
| 3876R | In distribution | |
| 4928 | In distribution | |
| 11448P | In distribution | |
| 11304RP | In distribution | |
| 3921 | In distribution | |
| 11303R | In distribution | |
| 3373R | 3.0″ Length x 1.323″ Width x 1.50″ Height | In distribution |
| 3069 | 9in (22.9cm) | In distribution |
| 3178R | In distribution | |
| 11340P | In distribution | |
| 3883RP | In distribution | |
| 11631 | In distribution | |
| 3874P | In distribution | |
| 11517 | In distribution | |
| 11512P | In distribution | |
| 3808R | In distribution | |
| 11880P | In distribution | |
| 3341R | 0.75″ Height | In distribution |
| 11384P | In distribution | |
| 4921P | In distribution | |
| 4604P | In distribution | |
| 11408 | In distribution | |
| 10707P | In distribution | |
| 3274 | 1.5in x 6in (3.8cm x 15.2cm) | In distribution |
| 3868R | In distribution | |
| 10269P | In distribution | |
| 3866R | In distribution | |
| 11403R | In distribution | |
| 3978 | In distribution | |
| 3030RP | In distribution | |
| 3595P | In distribution | |
| 11942P | In distribution | |
| 3640P | In distribution | |
| 3570P | In distribution | |
| 10708P | In distribution | |
| 4971 | In distribution | |
| 4017P | In distribution | |
| 4090P | In distribution | |
| 3772P | In distribution | |
| 11030 | In distribution | |
| 3167RP | In distribution | |
| 11962P | In distribution | |
| 11908 | In distribution | |
| 11303RP | In distribution | |
| 3483P | In distribution | |
| 4988P | In distribution | |
| 3375R | 5.0″ Length x 1.323″ Width x 1.50″ Height | In distribution |
| 3932 | In distribution | |
| 3650 | In distribution | |
| 11340 | In distribution | |
| 11904R | In distribution | |
| 4018RP | In distribution | |
| 11406 | In distribution | |
| 3928P | In distribution | |
| 10391P | In distribution | |
| 11962 | 1in x 5in (2.54cm x 12.7cm) | In distribution |
| 3782 | 1in x 6in (2.5cm x 15.2cm) | In distribution |
| 11826 | In distribution | |
| 3376RP | In distribution | |
| 4922P | In distribution | |
| 4936 | In distribution | |
| 3864 | In distribution | |
| 3870P | In distribution | |
| 4597P | In distribution | |
| 3044R | 3/4in (1.9cm) | In distribution |
| 3870 | In distribution | |
| 11514 | In distribution | |
| 3916 | In distribution | |
| 11385 | In distribution | |
| 11968 | In distribution | |
| 4959 | In distribution | |
| 4920P | In distribution | |
| 11385P | In distribution | |
| 11482 | In distribution | |
| 11875 | In distribution | |
| 10391 | In distribution | |
| 11966 | In distribution | |
| 3601P | In distribution | |
| 4920 | In distribution | |
| 3759P | In distribution | |
| 4967 | In distribution | |
| 11821 | In distribution | |
| 3225R | 1in x 1in (2.5cm x 2.5cm) | In distribution |
| 11921 | In distribution | |
| 3919 | In distribution | |
| 11482P | In distribution | |
| 11639P | In distribution | |
| 11931 | In distribution | |
| 10498P | In distribution | |
| 4598 | In distribution | |
| 3151RP | In distribution | |
| 11480 | In distribution | |
| 3630 | In distribution | |
| 10419P | In distribution | |
| 11900P | In distribution | |
| 3375RP | In distribution | |
| 3342 | 7/8in x 1/2in (2.2cm x 1.3cm) | In distribution |
| 11642P | In distribution | |
| 3104R | 0.75″ Height | In distribution |
| 3610P | In distribution | |
| 10269 | In distribution | |
| 11634 | In distribution | |
| 3220P | In distribution | |
| 4977 | In distribution | |
| 3604P | In distribution | |
| 3915 | In distribution | |
| 3098P | In distribution | |
| 11788 | In distribution | |
| 3150RP | In distribution | |
| 3923 | In distribution | |
| 11921 | In distribution | |
| 4603R | In distribution | |
| 4593P | In distribution | |
| 11925 | In distribution | |
| 4592P | In distribution | |
| 3780 | In distribution | |
| 11938P | In distribution | |
| 3926 | In distribution | |
| 11184 | In distribution | |
| 3616 | 1in x 1in (2.5cm x 2.5cm) | In distribution |
| 11382 | In distribution | |
| 11386P | In distribution | |
| 11634P | In distribution | |
| 11629P | In distribution | |
| 3882R | In distribution | |
| 11960 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Thompson | Thompson Surgical Instruments, Inc. | 4,354 |
| Millennium | Avalign Technologies, Inc. | 2,128 |
| Surtex | Surtex Instruments Ltd | 1,318 |
| Life Instruments | Life Instrument Corp. | 1,135 |
| Innomed, Inc. | Innomed, Inc. | 1,017 |
| Aesculap | Aesculap AG | 1,013 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 973 |
| Elmed | Elmed, Inc. | 919 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 891 |
| Boss Instruments | Boss Instruments, Ltd. | 799 |
| gSource | Gsource, LLC. | 753 |
| Sklar® | Sklar Corporation | 753 |
Showing 12 of 2,238. All products under Retractor
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.