FDA.reportPublic FDA data

NA

Primary DI
00849771013778
Brand
NA
Company
KEY SURGICAL, INC.
Model
CS-9113
Catalog number
CS-9113
Device description
Surgical Tray Corner Protectors, Lime Green
Published
2022-07-29
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
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.

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
00849771052708NAPlastic Sterilization TrayPST1100SB2023-01-26
00849771052159NAES50ES502023-01-26
00849771048237NAK-Wire and Steinmann Pin DispenserKI710172025-08-11
00849771049036NAK-Wires and Steinmann PinsKI711312025-08-11
00849771049289NAK-Wires and Steinmann PinsKI711852025-08-11
00849771049500NAK-Wires and Steinmann PinsKI712532025-08-11
00849771048169NAK-Wire and Steinmann Pin DispensersKI710022025-04-30
00849771049012NAK-Wires and Steinmann PinsKI711242025-04-30
00849771049128NAK-Wires and Steinmann PinsKI711612025-04-30
60849771050416Electro LubeEL101EL1012025-04-24
00849771046356K-Wire and Steinmann Pin DispensersKI71042KI710422025-04-16
00849771046363K-Wire and Steinmann Pin DispensersKI71044KI710442025-04-16
00849771046370K-Wire and Steinmann Pin DispensersKI71046KI710462025-04-16
00849771046387K-Wire and Steinmann Pin DispensersKI71047KI710472025-04-16
00849771046394K-Wire and Steinmann Pin DispensersKI71048KI710482025-04-16
00849771013372Key Surgical Cautery Tip CleanerTC200NSTC200NS2025-04-04
50849771050617NAK-Wire and Pin CoversC1092025-01-29
10724995225022Electro LubeEL201EL2012024-10-03
00849771048190NAK-Wire and Steinmann Pin DispensersKI710062024-10-03
00849771052562Key Surgical Pipe CleanersPC100CPC100C2024-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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50198956435382CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-24
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50198956332292CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
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