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
04046961025153Prontosan®B. BRAUN MEDICAL INC.FRO2026-08-09
00050428034873CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
00050428034880CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
10197344169429MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
10197344169436MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
00818582013802Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29
00852421007850Pure&CleanPure & Clean, LLCFRO2026-07-29
04260056880667XPERIENCE Advanced Surgical IrrigationOSARTIS GmbHFRO2026-07-28
10841495149815QUIKCLOTTELEFLEX INCORPORATEDFRO2026-07-27
B665AC510011AC5 Advanced Wound SystemArch Therapeutics, Inc.FRO2026-07-24
B665AVX030011VIA LinxArch Therapeutics, Inc.FRO2026-07-24
00852421007300Pure&CleanPure & Clean, LLCFRO2026-07-22
00818582012867Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00818582012881Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002451Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002475Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002536Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
09551012610479ELECTROCYN somaV3BIO SDN. BHD.FRO2026-07-16
10197344176007MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176014MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176021MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176038MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
04260056880650BLASTXOSARTIS GmbHFRO2026-07-12
00850088144604CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144611CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144628CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10