FDA.reportPublic FDA data

NA

Primary DI
00849771031567
Brand
NA
Company
KEY SURGICAL, INC.
Model
CS9125C
Catalog number
CS9125C
Device description
Surgical Tray Corner Protectors, Blue
Published
2023-04-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
10849771031564PrimaryGS10
00849771031567Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084977103156410849771031564
00849771031567008497710315678497710315670849771031567

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height1.25Inch
Length6Inch
Width6Inch

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
604056226
Device count
80
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
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
10198956592568CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956593886CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956603592CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956611856CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956612815CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956612921CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956619203CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956620957CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956623286CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956623507CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
B098AMS197690Aligned Medical SolutionsAligned Medical SolutionsLRP2026-10-23
03661219327929LANDANGERLANDANGERLRP2026-10-22
10198956558793CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956572447CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956578470CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956589575CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956599901CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956604216CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956611450CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956611863CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956617384CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956619241CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
00810161900992EARP, IMPLANT CADDY 14X25RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901005EARP, IMPLANT LID 14X25RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901012EARP, IMPLANT CADDY 14X30RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901029EARP, IMPLANT LID 14X30RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901036EARP, IMPLANT CADDY 14X35RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901043EARP, IMPLANT LID 14X35RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901050EARP, IMPLANT CADDY 14X40RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901067EARP, IMPLANT LID 14X40RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16