FDA.reportPublic FDA data

CL24426 Custom Med Label Pack

Primary DI
20787551022098
Brand
CL24426 Custom Med Label Pack
Company
XODUS MEDICAL, INC.
Model
CL24426
Catalog number
CL24426
Device description
CL24426 Custom Med Label Pack
Published
2023-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYVLABEL OR TAG, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYVLabel Or Tag, SterileGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20787551022098PackageGS1100In Commercial Distribution
00787551022094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2078755102209820787551022098
00787551022094007875510220947875510220940787551022094

GMDN Terms#

Term, Definition table
TermDefinition
Procedural medication labelling setA collection of devices intended to provide clinical staff with a standardized method to label medications, medication containers (e.g., syringes, medicine cups, basins), or other solutions in and outside of the sterile field in perioperative and other procedural settings. It typically includes a permanent marking pen and various labels typically made of moisture resistant plastic material and provided with standard medication/drug/solution text (e.g., lidocaine, heparin, morphine sulfate, saline, sterile water) which can be further qualified using the pen; the labels may also include additional text fields (e.g., for date, initials). This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
868042664
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
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
10198459214035Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-12-22
10198459218194Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-12-22
10198459218309Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-12-22
10198459204401Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-12-08
10198459205842Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-12-08
10198459189777Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-11-24
10198459166938Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-11-17
10198459181269Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-11-17
10198459159404Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-10-20
10198459148750Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-10-13
10198459141454Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-10-06
10198459141546Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-10-06
10198459133381Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-29
10198459134517Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-29
10198459122712Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-22
10198459122729Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-22
10198459122736Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-22
10198459115929Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459119774Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459119781Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459119798Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459120725Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459120732Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459109164Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-08
10198459074493Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-08-04
10198459075056Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-08-04
10198459078750Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-08-04
10195327655099Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-07-29
10195327668808Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-07-29
10198459024825Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-07-29