FDA.reportPublic FDA data

NuStat XR

Primary DI
10850392006169
Brand
NuStat XR
Company
BEEKEN BIOMEDICAL LLC
Model
XR-0408
Published
2024-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183190000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183190000NuStatBeeken Biomedical, LLC2019-09-25POD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850392006169PackageGS110In Commercial Distribution
00850392006162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085039200616910850392006169
00850392006162008503920061628503920061620850392006162

GMDN Terms#

Term, Definition table
TermDefinition
Wound dressing kit, non-medicatedA collection of instruments and dressings intended to be used to dress a wound. Items typically include scissors, forceps, gauze, and cotton-tip applicators; it does not contain a pharmaceutical. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
028807882
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850392006179NuStat Trauma Pad XRXR-08122021-01-08
00850392006544NuStat Trauma Pad XRXR-0812-52021-01-08
00850392006568NuStat Tactical NT-02362021-01-08
00850392006575NuStat N-0404-12021-01-08
00850392006582NuStat N-0404-22021-01-08
00850392006605NuStat Trauma Pad XRXR-0404-52021-01-08
00850392006247NuStat Flex XR30000973192021-01-08
00850392006278NuStat Flex XR30000973332021-01-08
00850392006155NuStatN-0404NT2023-03-01
00850392006162NuStat XRXR-04082024-02-20
00850392006599NuStat Trauma Pad XRXR-04042021-01-08
00850392006100NuStat FlexXR-03482023-05-04
00850392006223NuStat Flex XR30000973172021-01-08
00850392006230NuStat Flex XR30000973182021-01-08
00850392006261NuStat Flex XR30000973312021-01-08
00850392006506NuStat Flex XRXR-30000973312021-01-08
00850392006513NuStat Flex XRXR-30000973202021-01-08
00850392006520NuStat Flex XRXR-30000973332021-01-08
00850392006537NuStat Flex XRXR-30000973172021-01-08
00850392006254NuStat Flex XR30000973202021-01-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00714196111050DermaRite Medical DermaHoney Medical Grade Honey 0.5 oz TubeSion Brands LLCFRO2026-06-01
00714196111074DermaRite Medical DermaHoney Medical Grade Honey 1.75 oz TubeSion Brands LLCFRO2026-06-01
01714196222045DermaRite Medical DermaHoney Tulle Non Border Honey Gauze 4x4Sion Brands LLCFRO2026-06-01
01714196333048DermaRite Medical DermaHoney Border Medical Grade Honey Sheet 4x4Sion Brands LLCFRO2026-06-01
08717249680130DermaRite Medical L-Mesitran 0.5 oz TubeSion Brands LLCFRO2026-06-01
08717249680147DermaRite Medical L-Mesitran 1.75 oz TubeSion Brands LLCFRO2026-06-01
00850087488259CeeportCEEPORT INC.FRO2026-05-29
00850087488266CeeportCEEPORT INC.FRO2026-05-29
10080196415397MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415386MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415393MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677289MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677296MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
00850087488006CeeportCEEPORT INC.FRO2026-05-22
10197344175994MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-20
10840330706688ProCureTwin Med, LLCFRO2026-05-04
09551012610035ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610196ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610363ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610370ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
10192253046403KendallCardinal Health 200, LLCFRO2026-03-25
10192253046519KendallCardinal Health 200, LLCFRO2026-03-25
09120073781536GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781543GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781550GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781567GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781574GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
10197344169412MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
10197344169443MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
10197344169467MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07