SUNDER

Primary DI
04711552764857
Brand
SUNDER
Company
SUNDER BIOMEDICAL TECH. CO., LTD.
Model
SD-A16G
Device description
S-04-C15-B-03
Published
2026-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FIENeedle, Fistula

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FIENeedle, FistulaGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003123000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003123000RENAX A.V. FISTULA NEEDLE SETSSunder Biomedical Tech. Co., Ltd.2001-05-04FIE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04711552764857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04711552764857047115527648574711552764857

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis needleA sterile, sharp bevel-edged, hollow tubular metal instrument used to remove and return a patient's blood during a haemodialysis procedure. Commonly known as a dialysis needle. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
657715348
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04711552764666SUNDERSD-G012026-04-24
04711552760026SUNDERSD-K012026-04-23
04711552761498SUNDERSD-K012026-04-23
04711552764048SUNDERSD-K012026-04-23
04711552764086SUNDERSD-K012026-04-23
04711552764758SUNDERSD-K012026-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842289102743masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102750masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102767masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102774masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102781masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102798masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102804masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102811masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102828masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102835masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102842masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102859masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102866masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102873masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102880masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102897masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102903masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102910masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102927masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102934masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102941masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102958masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102965masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102972masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102989masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102460ButtonHole SINGLE NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-06
00842289102590NxStage SINGLE NEEDLE FISTULA SETNXSTAGE MEDICAL, INC.FIE2020-07-06
00842289102644NxStage SINGLE NEEDLE FISTULA SETNXSTAGE MEDICAL, INC.FIE2020-07-06
00842289102668masterguard APHERESIS NEEDLENXSTAGE MEDICAL, INC.FIE2020-07-06
00842289102675masterguard APHERESIS NEEDLENXSTAGE MEDICAL, INC.FIE2020-07-06