keysurgical.com
xx.xxUniversal Light Handle Cover, Light Handle Cover
Key Surgical, Inc.
Key Surgical, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2183785 | 2183785 | Key Surgical, LLC | 1 | N | 2026-01-01 | 8101 Wallace Road Eden Prairie MN US 55344 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00849771031284 | Key Surgical Silicone Clamp Covers - Silicone Clamp Covers, Sterile, Blue, 0.29-inch 7.40mm x 5-inch, | +1(800)548-4873 | xx@xx.xx |
| 00849771048367 | NA - Plastic Instruments, Angled Towel Clamp, round tip, 4.5-inch, blue | +1(800)548-4873 | xx@xx.xx |
| 00849771048374 | NA - Plastic Instruments, Angled Towel Clamp, oblong tip, 4.75-inch, light green | +1(800)541-7995 | regulatory@keysurgical.com |
| 00849771048374 | NA - Plastic Instruments, Angled Towel Clamp, oblong tip, 4.75-inch, light green | +1(800)548-4873 | xx@xx.xx |
| 00849771048626 | NA - Plastic Sterilization Tray with Slotted Base, Insert Tray and 2 Silicone Mat, 10.0-inch x 6.0-inch x 1.5-inch 254 x 152 x 38mm | +1(800)541-7995 | regulatory@keysurgical.com |
| 00849771048626 | NA - Plastic Sterilization Tray with Slotted Base, Insert Tray and 2 Silicone Mat, 10.0-inch x 6.0-inch x 1.5-inch 254 x 152 x 38mm | +1(800)548-4873 | xx@xx.xx |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 72617 | 1707153203 | K993604 | ENDOSCOPIC ANTI FOG DEVICE | OCT | 2000-03-03 |
| 72617 | 1265408197 | K932449 | DR. FOG | OCT | 1993-08-11 |
| 72617 | 1962248427 | K896676 | KEY VASCULAR LOOPS | KDC | 1990-02-27 |
| 72617 | 1079061016 | K890759 | STRIP, STERILIZATION INDICATOR; STEAM | JOJ | 1989-08-07 |
| 72617 | 1099370445 | K890755 | SEALING TAPE, STERILIZATION INDICATOR; STEAM | JOJ | 1989-08-07 |
| 72617 | 1002511326 | K242773 | Electro Lube NXT | GEI | 2025-04-15 |
| 72617 | 2038338892 | K241055 | Electro Lube NXT | GEI | 2024-05-31 |
| 72617 | 1264422675 | K191231 | Andorate Auxiliary Water Connector, Andorate Valves Set | ODC | 2019-06-07 |
| 72617 | 1484223413 | K182998 | Andorate Auxiliary Water Connector | OCX | 2019-04-17 |
| 72617 | 1268957500 | K172729 | Polypectomy Snare | FDI | 2018-05-21 |
| 72617 | 1593624548 | K172727 | Hemoclip | PKL | 2018-04-16 |
| 72617 | 1874003718 | K171533 | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap | FRG | 2017-06-29 |
| 72617 | 1525122994 | K160755 | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap | FRG | 2016-07-27 |
| 72617 | 1233073786 | K151222 | Cautery Tip Cleaner | GEI | 2015-05-22 |
| 72617 | 1751695892 | K102845 | MAHE FIXATION PLATE AND SCREW SYSTEM | HRS | 2011-05-13 |
| 72617 | 1127369308 | K033880 | ELECTRO-LUBE | GEI | 2004-03-10 |
| 72617 | 1191517125 | ||||
| 72617 | 1709869248 | ||||
| 72617 | 1714441427 | ||||
| 72617 | 1742180672 | ||||
| 72617 | 1905545790 | ||||
| 72617 | 2020935082 | ||||
| 72617 | 1082348839 | ||||
| 72617 | 1123599402 | ||||
| 72617 | 1213120155 | ||||
| 72617 | 1230686073 | ||||
| 72617 | 1241062654 | ||||
| 72617 | 1337605906 | ||||
| 72617 | 1375120948 | ||||
| 72617 | 1389457720 | ||||
| 72617 | 1581742185 | ||||
| 72617 | 1642173534 | ||||
| 72617 | 1674951817 | ||||
| 72617 | 1883457946 | ||||
| 72617 | 1893305740 | ||||
| 72617 | 1937890573 | ||||
| 72617 | 1954969229 | ||||
| 72617 | 2006514372 | ||||
| 72617 | 2024573493 | ||||
| 72617 | 2072862996 |
Product Codes Associated With Registrations#
PMN#
Cautery Tip Cleaner
KEY SURGICAL, INC.
KEY COMFORT GRIPS
KEY SURGICAL, INC.
KEY VASCULAR LOOPS
KEY SURGICAL, INC.
KEY VASCULAR BOOTIES
KEY SURGICAL, INC.
SILICONE INSTRUMENT SHODS
KEY SURGICAL, INC.
GUDID#
NA - Plastic Instruments, Angled Towel Clamp, oblong tip, 4.75-inch, light green
2023-04-04
NA - Plastic Instruments, Angled Towel Clamp, round tip, 4.5-inch, blue
2023-01-26
Key Surgical Silicone Clamp Covers - Silicone Clamp Covers, Sterile, Blue, 0.29-inch 7.40mm x 5-inch,
2020-12-09
NA - Silicone Clamp Covers, Non-Sterile, Blue, 0.29-inch 7.40mm x 5-inch
2023-01-26
NA - Silicone Clamp Covers, Non-Sterile, White, 0.21-inch 5.35mm x 5-inch
2023-01-26
NA - Silicone Clamp Covers, Non-Sterile, Red, 0.14-inch 3.60mm x 5-inch
2023-03-31
Key Surgical Cautery Tip Cleaner - Cautery Tip Cleaner, 50mm x 50mm, sterile, pouch
2025-04-04
NA - Plastic Sterilization Tray with Slotted Base, Insert Tray and 2 Silicone Mat, 10.0-inch x 6.0-inch x 1.5-inch 254 x 152 x 38mm
2023-05-08
NA - Plastic Sterilization Tray with Slotted Base and Silicone Mat; 7.5-inch x 2.5-inch x 0.75-inch 190.5 x 63.5 x 19mm
2023-01-26
NA - Plastic Sterilization Tray with Slotted Base and Silicone Mat; 254 x 152 x 38mm
2023-01-26
NA - Plastic Sterilization Tray with Slotted Base and Silicone Mat; 6-inch x 2.5-inch x 0.75-inch 152 x 63.5 x 19mm
2023-01-26
NA - Plastic Sterilization Tray with Slotted Base and Silicone Mat; 10.0-inch x 6.0-inch x 1.5-inch 254 x 152 x 38mm
2023-01-26
NA - Plastic Sterilization Tray with Slotted Base and Silicone Mat; 10.0-inch x 6.0-inch x 0.75-inch 254 x 152 x 19mm
2023-01-26
NA - Plastic Sterilization Tray with Slotted Base and Silicone Mat; 6.5-inch x 4.0-inch x 0.75-inch 165 x 102 x 19mm
2023-01-26
NA - Instrument Organizer, 5-inch x 12-inch Single pocket
2022-11-22
NA - Instrument Organizer, 5-inch x 5.75-inch single pocket
2022-11-22
NA - Instrument Organizer, 10.75-inch x 19-inch, 2 rows of 6 notched pockets with tape closure strips
2022-11-22
NA - Instrument Organizer, 16.25-inch x 17.25-inch, 2 rows of 6 pockets with foldover flap
2022-11-22
NA - Instrument Organizer, 12-inch x 17.5-inch, 2 rows of 6 pockets with slots, closure strips included
2022-11-22
NA - Instrument Organizer, 12-inch x 17.5-inch, 2 rows of 6 pockets with slots in pockets
2022-11-22
NA - Instrument Organizer, 12.5-inch x 17.25-inch, 2 rows of 6 pockets
2022-11-22
NA - Instrument Tray, 2.5-inch Pan 22 Gauge
2023-11-02
NA - K-Wire Covers, Sterile, White,
2024-10-03
Key Surgical K-Wire and Pin Covers - Pin Covers, Non-Sterile, Brown, 0.137-inch, 3.5mm, Bulk
2020-12-09
Key Surgical K-Wire and Pin Covers - Pin Covers, Non-Sterile, Navy, .156-inch, 4.0mm, Bulk
2020-12-09
Key Surgical K-Wire and Pin Covers - K-Wire Covers, Non-Sterile, White, .043-inch, 1.1mm, Bulk
2020-12-09
NA - Dry Endoscopy Sponge, 2-inch OD x 0.50-inch ID x 3.75-inch Long
2023-01-26
NA - Dry Endoscopy Sponge, 2-inch OD x 0.50-inch ID x 3.75-inch Long
2023-01-26
NA - K-Wires, Single diamond, round end, .062-inch (1.6mm) diameter, 12-inch
2025-08-11
NA - K-Wires, Single trocar, .062-inch (1.6mm) diameter, 6-inch long
2025-08-11
NA - K-Wires, Single trocar, .035-inch (.9mm) diameter, 4-inch long
2025-08-11
NA - K-Wire and Steinmann Pin Dispensers, 5/64-inch (2.0mm) diameter, Holds pins up to 12-inch long
2025-08-11
NA - K-Wires, Single diamond, round end, .062-inch (1.6mm) diameter, 12-inch
2025-08-11
NA - K-Wires, Single trocar, .062-inch (1.6mm) diameter, 6-inch long
2025-08-11
NA - K-Wires, Single trocar, .035-inch (.9mm) diameter, 4-inch long
2025-08-11
K-Wire and Steinmann Pin Dispensers - K-Wire and Steinmann Pin Dispensers, 5/64-inch (2.0mm) diameter, Holds pins up to 12-inch long
2020-12-21
Key Surgical K-Wires and Steinmann Pins - K-Wires, Single diamond, round end, .062-inch (1.6mm) diameter, 12-inch
2020-12-22
Key Surgical K-Wires and Steinmann Pins - K-Wires, Single trocar, .062-inch (1.6mm) diameter, 6-inch long
2020-12-22
Key Surgical K-Wires and Steinmann Pins - K-Wires, Single trocar, .035-inch (.9mm) diameter, 4-inch long
2020-12-22
Electro Lube - Electro Lube NXT is an anti-stick solution to prevent tissue sticking and eschar buildup during electrosurgery and has been validated for use with open, minimally invasive, and robotic instruments.
2024-10-03