FDA.reportPublic FDA data

"40461 Surgical Tray Corner Protectors (6"" x 6"" x 1.25"" set of 4)"

Primary DI
00787551013238
Brand
"40461 Surgical Tray Corner Protectors (6"" x 6"" x 1.25"" set of 4)"
Company
XODUS MEDICAL, INC.
Model
40461
Catalog number
40461
Device description
"40461 Surgical Tray Corner Protectors (6"" x 6"" x 1.25"" set of 4)"
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20787551013232PackageGS1100In Commercial Distribution
00787551013238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2078755101323220787551013232
00787551013238007875510132387875510132380787551013238

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray corner protector, single-useA 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 single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(724)337-5500plloyd@xodusmedical.com

Regulatory Flags#

DUNS number
868042664
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true

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00787551041613SPK11759 Jackson Table KitSPK11759SPK117592026-04-30
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