FDA.reportPublic FDA data

"80855 Reusable Magnetic Transfer Zone 12"" x 8"""

Primary DI
00787551013511
Brand
"80855 Reusable Magnetic Transfer Zone 12"" x 8"""
Company
XODUS MEDICAL, INC.
Model
80855
Catalog number
80855
Device description
"80855 Reusable Magnetic Transfer Zone 12"" x 8"""
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20787551013515PackageGS13In Commercial Distribution
00787551013511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2078755101351520787551013515
00787551013511007875510135117875510135110787551013511

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument interim-placement holder, reusableA device intended to be used in the operating room (OR) by staff to safely hold a manual, surgical instrument(s) [e.g., needle, scalpel, scissors] when not in use during surgery, to avoid damage to the instrument, and/or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, puncture cushion, telescopic tube, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. This is a reusable 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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00787551041439LPK10035 Lateral Positioning KitLPK10035LPK100352026-04-30
00787551041446CL25313 Custom Med Label PackCL25313CL253132026-04-30
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0078755104155280564 Camel Mat - Ultra Absorbent Mat (Extra Large) w/ Adhesive80564805642026-04-30
00787551041569CL25312 Custom Med Label PackCL25312CL253122026-04-30
0078755104157640672 Hot Pink Pad XL40672406722026-04-30
00787551041583SPK11715 Jackson KitSPK11715SPK117152026-04-30
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00787551041613SPK11759 Jackson Table KitSPK11759SPK117592026-04-30
00787551041385LPK10033 Lateral Positioning KitLPK10033LPK100332026-01-20

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