FDA.report

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

Related Records

Contact Domains

Product Codes

CodeName
LRPTRAY, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10849771031564PrimaryGS10
00849771031567Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084977103156410849771031564
00849771031567008497710315678497710315670849771031567

GMDN Terms

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

TypeValueUnit
Height1.25Inch
Length6Inch
Width6Inch

Sterilization Methods

Method

Contacts

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

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