FDA.reportPublic FDA data

"40463 Reticulated Surgical Tray Corner Protectors (6"" x 6"" x 1.625"" set of 4)"

Primary DI
00787551013252
Brand
"40463 Reticulated Surgical Tray Corner Protectors (6"" x 6"" x 1.625"" set of 4)"
Company
XODUS MEDICAL, INC.
Model
40463
Catalog number
40463
Device description
"40463 Reticulated Surgical Tray Corner Protectors (6"" x 6"" x 1.625"" 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
20787551013256PackageGS180In Commercial Distribution
00787551013252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2078755101325620787551013256
00787551013252007875510132527875510132520787551013252

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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0078755104159040673 Hot Pink Pad EXT - with Arm Protectors40673406732026-04-30
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00787551041613SPK11759 Jackson Table KitSPK11759SPK117592026-04-30
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