FDA.reportPublic FDA data

NA

Primary DI
10849771013775
Brand
NA
Company
KEY SURGICAL, INC.
Model
CS-9113
Catalog number
CS9113
Device description
Surgical Tray Corner Protectors, Lime Green
Published
2022-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRPTRAY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849771013775PrimaryGS10
00849771013778Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084977101377510849771013775
00849771013778008497710137788497710137780849771013778

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray corner protector, reusableA device designed to cover the sharp corners of an instrument tray before the tray is wrapped with sterilization packaging (wrap), to protect the wrap from tearing and the tray corners from damage. It is typically made of synthetic polymer materials. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)541-7995regulatory@keysurgical.com

Regulatory Flags#

DUNS number
604056226
Device count
80
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10849771050374NASilicone Clamp CoversVS2012023-03-31
10849771050381NASilicone Clamp CoverVS2022023-01-26
10849771050398NASilicone Clamp CoverVS2032023-01-26
00849771031284Key Surgical Silicone Clamp CoversVS-103VS1032020-12-09
00849771048367NASurgical Plastic InstrumentKS3472023-01-26
00849771048374NASurgical Plastic InstrumentsKS3482023-04-04
10849771013379Key Surgical Cautery Tip CleanerTC200NSTC200NS2025-04-04
00849771048596NAPlastic Sterilization TrayPST2100SB2023-01-26
00849771048602NAPlastic Sterilization TrayPST3100SB2023-01-26
00849771048619NAPlastic Sterilization TrayPST3200SB2023-01-26
00849771052692NAPlastic Sterilization TrayPST0100SB2023-01-26
00849771052715NAPlastic Sterilization TrayPST3200SBC12023-01-26
00849771052708NAPlastic Sterilization TrayPST1100SB2023-01-26
00849771048626NAPlastic Sterilization TraysPST3300SB2023-05-08
10849771047428NAInstrument OrganizerCSDH1002022-11-22
10849771047435NAInstrument OrganizerCSDH1022022-11-22
10849771047442NAInstrument OrganizerCSDH1052022-11-22
10849771047459NAInstrument OrganizerCSDH3002022-11-22
10849771047466NAInstrument OrganizerCSDH2002022-11-22
10849771047473NAInstrument OrganizerCSDH5052022-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091278ELMED INCORPORATEDELMED INCORPORATEDLRP2026-06-09
04052536163434neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536164585neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536164592neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536164608neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536177516neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536221202uCentumUlrich GmbH & Co. KGLRP2026-06-09
04052536221219uCentumUlrich GmbH & Co. KGLRP2026-06-09
04052536221233uCentumUlrich GmbH & Co. KGLRP2026-06-09
04052536162116neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536162130neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536162147neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536162154neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536162215neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536176724neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536176748neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536176755neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536176762neon3Ulrich GmbH & Co. KGLRP2026-06-08
10198956433755CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956461109CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956476950CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956479999CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956485112CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956487475CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956490109CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956490635CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956494817CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956501362CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956505841CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956506381CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08