FDA.reportPublic FDA data

Oasis

Primary DI
00643293008980
Brand
Oasis
Company
TRULIFE LIMITED
Model
OA061
Device description
Oasis Ulnar/Brachial Nerve Protector
Published
2023-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JZRSUPPORT GELS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZRSupport GelsImmunology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643293008980PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643293008980006432930089806432930089800643293008980

Regulatory Flags#

DUNS number
985048669
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00645517899312TrulifeTN200-22026-04-22
00645517899329TrulifeTN200-32026-04-22
00645517899336TrulifeTN200-42026-04-22
00645517899343TrulifeTN200-52026-04-22
00645517899398TrulifeTN200-KIT2026-04-22
00645517899404TrulifeTN250-KIT2026-04-22
00645517899350TrulifeTN250-22026-02-17
00645517899367TrulifeTN250-32026-02-17
00645517899374TrulifeTN250-42026-02-17
00645517899381TrulifeTN250-52026-02-17
00645517024189Trulife08005042025-09-03
00645517323831TrulifeO109012025-09-03
00645517323848TrulifeO109022025-09-03
00645517323886TrulifeO109312025-09-03
00645517323947TrulifeO113942025-09-03
00645517510729TrulifeO109272025-09-03
00645517510743TrulifeO109282025-09-03
00645517024172Trulife08005022023-06-06
00645517325002TrulifeA378022022-12-31
00645517324104Trulife1400027R002022-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
26952534431011SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.JZR2023-04-06
26952534431028SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.JZR2023-04-06
26952534431035SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.JZR2023-04-06
00643293028858AzureTRULIFE LIMITEDJZR2023-02-10
00643293028865AzureTRULIFE LIMITEDJZR2023-02-10
00643293028872AzureTRULIFE LIMITEDJZR2023-02-10
00643293028889AzureTRULIFE LIMITEDJZR2023-02-10
00643293028896AzureTRULIFE LIMITEDJZR2023-02-10
00643293028902AzureTRULIFE LIMITEDJZR2023-02-10
00643293028919Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293028926Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293028933Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293028940Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293028957Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293028964Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293028971Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293028988Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293028995Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293029008Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293029015Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293029022EliteTRULIFE LIMITEDJZR2023-02-10
00643293029039EliteTRULIFE LIMITEDJZR2023-02-10
00643293029046OasisTRULIFE LIMITEDJZR2023-02-10
00643293029053OasisTRULIFE LIMITEDJZR2023-02-10
00643293029060OasisTRULIFE LIMITEDJZR2023-02-10
00643293029077OasisTRULIFE LIMITEDJZR2023-02-10
00643293029084OasisTRULIFE LIMITEDJZR2023-02-10
00643293029091OasisTRULIFE LIMITEDJZR2023-02-10
00643293029107OasisTRULIFE LIMITEDJZR2023-02-10
00643293029114OasisTRULIFE LIMITEDJZR2023-02-10