FDA.reportPublic FDA data

50511 Double Dispenser Rack Four Sets of Hooks IV Pole Only

Primary DI
00787551012354
Brand
50511 Double Dispenser Rack Four Sets of Hooks IV Pole Only
Company
XODUS MEDICAL, INC.
Model
50511
Catalog number
50511
Device description
50511 Double Dispenser Rack Four Sets of Hooks IV Pole Only
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
FQASCALE, SURGICAL SPONGE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQAScale, Surgical SpongeGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20787551012358PackageGS11In Commercial Distribution
00787551012354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2078755101235820787551012358
00787551012354007875510123547875510123540787551012354

GMDN Terms#

Term, Definition table
TermDefinition
Surgical sponge-counting bagA device in the form of a bag intended to be used in the operating room (OR) to store and maintain the count of surgical sponges/swabs during a surgical procedure to prevent these items from being inadvertently left in a patient. It is a bag with individual pockets/sections and is typically hung on an associated rack (not included); it may be weighed following sponge/swab collection to calculate blood loss. 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00787551041675LPK10036 Lateral Positioning KitLPK10036LPK100362026-10-19
00787551041682SPK10756 Surgical BackPack KitSPK10756SPK107562026-10-19
00787551041699NSCL24484 Custom Med Label PackNSCL24484NSCL244842026-10-19
00787551041705NSCL25027 Custom Med Label PackNSCL25027NSCL250272026-10-19
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00787551041637SPK11761 Jackson Table KitSPK11761SPK117612026-07-27
00787551041644SPK11773 Surgical BackPack KitSPK11773SPK117732026-07-27
00787551041651SPK11774 Surgical BackPack KitSPK11774SPK117742026-07-27
0078755100057330500 Cautery Tip Cleaner30500305002017-05-01
0078755101304740670 Hot Pink Pad Controller (Assembled)40670406702026-04-30
0078755104140840671 Hot Pink Pad XL - with Arm Protectors40671406712026-04-30
00787551041415SPK11731 Jackson Table KitSPK11731SPK117312026-04-30
0078755104142240697 The Pink Pad XL - Advanced Trendelenburg Positioning Kit with Adult Head R40697406972026-04-30
00787551041439LPK10035 Lateral Positioning KitLPK10035LPK100352026-04-30
00787551041446CL25313 Custom Med Label PackCL25313CL253132026-04-30
0078755104153840440 Trendelenburg One-Step Arm Protectors Low Profile40440404402026-04-30
0078755104154580566 Camel Mat - Ultra Absorbent Mat (Large) w/ Adhesive80566805662026-04-30
0078755104155280564 Camel Mat - Ultra Absorbent Mat (Extra Large) w/ Adhesive80564805642026-04-30
00787551041569CL25312 Custom Med Label PackCL25312CL253122026-04-30

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