FDA.reportPublic FDA data

50500 Sponge Counter Bag Blue

Primary DI
00787551012309
Brand
50500 Sponge Counter Bag Blue
Company
XODUS MEDICAL, INC.
Model
50500
Catalog number
50500
Device description
50500 Sponge Counter Bag Blue
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
10787551012306PackageGS150In Commercial Distribution
20787551012303PackageGS1250In Commercial Distribution
00787551012309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1078755101230610787551012306
2078755101230320787551012303
00787551012309007875510123097875510123090787551012309

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
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
0078755104157640672 Hot Pink Pad XL40672406722026-04-30
00787551041583SPK11715 Jackson KitSPK11715SPK117152026-04-30
0078755104159040673 Hot Pink Pad EXT - with Arm Protectors40673406732026-04-30
0078755104160640674 Hot Pink Pad EXT40674406742026-04-30
00787551041613SPK11759 Jackson Table KitSPK11759SPK117592026-04-30
00787551041385LPK10033 Lateral Positioning KitLPK10033LPK100332026-01-20
00787551041392LPK10034 Lateral Positioning KitLPK10034LPK100342026-01-20
20787551041389LPK10033 Lateral Positioning KitLPK10033LPK100332026-01-20
20787551041396LPK10034 Lateral Positioning KitLPK10034LPK100342026-01-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850013361441Doran ScalesDORAN SCALES, INC.FQA2023-11-14
0078755101234750510 Single Dispenser Rack Two Sets of Hooks In Front Wall & IV PoleXODUS MEDICAL, INC.FQA2022-12-08
0078755101235450511 Double Dispenser Rack Four Sets of Hooks IV Pole OnlyXODUS MEDICAL, INC.FQA2022-12-08
0078755101239250600 Sponge Counter Bags ClearXODUS MEDICAL, INC.FQA2022-12-08
00850013361250Doran ScalesDORAN SCALES, INC.FQA2022-05-31
00850013361267Doran ScalesDORAN SCALES, INC.FQA2022-05-31
00850013361274Doran ScalesDORAN SCALES, INC.FQA2022-05-31
00850013361281Doran ScalesDORAN SCALES, INC.FQA2022-05-31
00850013361298Doran ScalesDORAN SCALES, INC.FQA2022-05-31
00850013361304Doran ScalesDORAN SCALES, INC.FQA2022-05-31
00850013361403Doran ScalesDORAN SCALES, INC.FQA2022-05-31
00850013361410Doran ScalesDORAN SCALES, INC.FQA2022-05-31
00850013361427Doran ScalesDORAN SCALES, INC.FQA2022-05-31
08300496042235SOLIDEACALZIFICIO PINELLI SRLFQA2020-07-22
00809161142709DetectoCARDINAL SCALE MANUFACTURING COMPANYFQA2017-10-18
00809161201901DetectoCARDINAL SCALE MANUFACTURING COMPANYFQA2017-10-18
00849686073669NoninNONIN MEDICAL, INC.FQA2017-02-22
00833166008722NoninNONIN MEDICAL, INC.FQA2017-02-22