FDA.reportPublic FDA data

Self-retaining surgical retractor, single-use

Definition
A sterile, hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a single-use device.
GUDID devices
160
Last updated
2026-07-25 06:05:12

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07613327651133VersiQuadSTRYKER CORPORATION02341121002026-07-16
07640177823564Neo Medical RetractorsNeo Medical SARP-00-40-002026-07-10
07640177823571Neo Medical RetractorsNeo Medical SARP-00-50-002026-07-10
07640177823588Neo Medical RetractorsNeo Medical SARP-00-60-002026-07-10
07640177823595Neo Medical RetractorsNeo Medical SARP-00-70-002026-07-10
07640177823601Neo Medical RetractorsNeo Medical SARP-00-80-002026-07-10
07640177823748Neo Medical RetractorsNeo Medical SARP-00-40-BL2026-07-10
07640177823755Neo Medical RetractorsNeo Medical SARP-00-50-BL2026-07-10
07640177823762Neo Medical RetractorsNeo Medical SARP-00-60-BL2026-07-10
07640177823779Neo Medical RetractorsNeo Medical SARP-00-70-BL2026-07-10
07640177823786Neo Medical RetractorsNeo Medical SARP-00-80-BL2026-07-10
07640177823793Neo Medical RetractorsNeo Medical SARP-00-90-BL2026-07-10
07640177823809Neo Medical RetractorsNeo Medical SARP-00-AK-002026-07-10
07640177823007Neo Medical RetractorsNeo Medical SARL-01-20-NS2024-02-06
07640177823021Neo Medical RetractorsNeo Medical SARL-01-60-NS2024-02-06
07640177823038Neo Medical RetractorsNeo Medical SARL-01-80-NS2024-02-06
07640177823045Neo Medical RetractorsNeo Medical SARL-00-AK-NS2024-02-06
07640177823502Neo Medical RetractorsNeo Medical SARP-00-40-NS2024-02-06
07640177823519Neo Medical RetractorsNeo Medical SARP-00-50-NS2024-02-06
07640177823526Neo Medical RetractorsNeo Medical SARP-00-60-NS2024-02-06
07640177823533Neo Medical RetractorsNeo Medical SARP-00-70-NS2024-02-06
07640177823540Neo Medical RetractorsNeo Medical SARP-00-80-NS2024-02-06
07640177823557Neo Medical RetractorsNeo Medical SARP-00-AK-NS2024-02-06
00850067560203MaxRetractSurgical Principals, Inc3302G-SPI2025-10-23
00850067560210MaxRetractSurgical Principals, Inc3308G-SPI2025-10-23
00850067560296MaxRetractSurgical Principals, Inc3301G-SPI 2025-10-23
00850067560302MaxRetractSurgical Principals, Inc3309G-SPI 2025-10-23
00860006484859MaxRetractSurgical Principals, Inc3715-SPI2025-10-23
00860006484866MaxRetractSurgical Principals, Inc3307G-SPI2025-10-23
00860006484873MaxRetractSurgical Principals, Inc3304G-SPI2025-10-23
00888937003789Mobius Elastic RetractorCoopersurgical, Inc.900-5002016-06-07
00888937003796Mobius Elastic RetractorCoopersurgical, Inc.900-5082016-06-07
00888937003802Mobius Elastic RetractorCoopersurgical, Inc.900-5152016-06-07
00888937003819Mobius Elastic RetractorCoopersurgical, Inc.900-5172016-06-07
00888937003826Mobius Elastic RetractorCoopersurgical, Inc.900-5202016-06-07
04026704599745WECKTELEFLEX INCORPORATEDIPN0064312018-05-15
04026704599752WECKTELEFLEX INCORPORATEDIPN0064322018-05-15
04046963359515SUSIAesculap AGBV067SU2020-04-23
04046963361747SUSIAesculap AGBT028SU2020-04-23
05060480406582Retractor West Self Retaining (Sharp)BLINK MEDICAL LIMITEDHR7042023-01-17
10649111196478Sklar®SKLAR CORPORATION22-78552018-08-02
10649111254703Sklar®SKLAR CORPORATION22-82302018-08-02
10649111255045Sklar®SKLAR CORPORATION22-82322018-08-02
10649111256776Sklar®SKLAR CORPORATION22-82452018-08-02
10649111258299Sklar®SKLAR CORPORATION22-82552018-08-02
10649111270987Sklar®SKLAR CORPORATION22-83452018-07-26
10649111272509Sklar®SKLAR CORPORATION22-83552018-07-26
10649111334245Sklar®SKLAR CORPORATION22-87602018-07-26
10649111352027Sklar®SKLAR CORPORATION22-88602018-07-26
10649111390371Sklar®SKLAR CORPORATION22-8245C2018-08-02
10649111390388Sklar®SKLAR CORPORATION22-8255C2018-08-02
10649111390401Sklar®SKLAR CORPORATION22-8345C2018-07-26
10649111390418Sklar®SKLAR CORPORATION22-8355C2018-07-26
10649111390463Sklar®SKLAR CORPORATION22-8860C2018-07-26
10850067560286MaxRetractSurgical Principals, Inc3350L-4-SPI2025-10-23
10884523000771Endo Paddle RetractCovidien LP1730462018-08-10
10884523000801Endo Mini-RetractCovidien LP1742092016-09-24
10884523000825Endo RetractCovidien LP1743112018-08-10
10884523000849Endo RetractCovidien LP1766132018-08-10
10884523000856Endo Retract IICovidien LP1766472016-09-24
10888439920659CARDINAL HEALTHCardinal Health 200, LLCFGS-0502021-06-18
14026704631749WECKTELEFLEX INCORPORATEDIPN0284962018-08-24
14026704631756WECKTELEFLEX INCORPORATEDIPN0284972018-08-24
M209200610Effi+Pro® Compression/Distraction KitBIOPRO, INC.200612015-09-16
M209201890EFFI+PRO STERILIZATION TRAYBIOPRO, INC.201892015-09-16
M209201900EFFI+PRO STERILIZATION LIDBIOPRO, INC.201902015-09-16
M209201910EFFI+PRO RATCHETBIOPRO, INC.201912015-09-16
M209201920EFFI+PRO COMPRESSION/DISTRACTION UNITBIOPRO, INC.201922015-09-16
M209201930EFFI+PRO PIN 2.8MM/5-COILBIOPRO, INC.201932015-09-16
M209201940EFFI+PRO PIN 2.8MM/4.5BIOPRO, INC.201942015-09-16
M209201950EFFI+PRO PIN 2.4MM/4.5BIOPRO, INC.201952015-09-16
M209201960EFFI+PRO PIN 3.0MMBIOPRO, INC.201962015-09-16
M209201970EFFI+PRO PIN 2.4MMBIOPRO, INC.201972015-09-16
M209201980EFFI+PRO PIN 2.5MM COILBIOPRO, INC.201982015-09-16
M209201990EFFI+PRO PIN 2..6MM COILBIOPRO, INC.201992015-09-16
00194613010959MSI Precision Specialty InstrumentsMed Saver, Inc.5-54919S-DS-IND2025-08-01
00194613029708MSI Precision Specialty InstrumentsMed Saver, Inc.24139-61772025-08-01
00194613030759MSI Precision Specialty InstrumentsMed Saver, Inc.30-134-12025-08-01
00194613029692MSI Precision Specialty InstrumentsMed Saver, Inc.24139-61722025-03-21
00860011767909Watson Flex Retractor SystemBIOPHYX LLC100102024-12-11