FDA.reportPublic FDA data

AVALON BIOMED

Primary DI
06978880223267
Brand
AVALON BIOMED
Company
Shanghai Xing Yu Medical Equipment Co.,Ltd.
Model
T0.06/45#/100pc/marked
Published
2026-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Product Codes#

Code, Name table
CodeName
EKNPoint, Paper, Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKNPoint, Paper, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06978880223267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06978880223267069788802232676978880223267

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic paper pointA non-medicated absorbent point used in endodontic procedures that has been sterilized once in a manner approved by the manufacturer. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
529128752
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
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
06978880220006ZarcT0.02/15#/200pc2026-03-09
06978880220013ZarcT0.02/20#/200pc2026-03-09
06978880220020ZarcT0.02/25#/200pc2026-03-09
06978880220037ZarcT0.02/30#/200pc2026-03-09
06978880220044ZarcT0.02/35#/200pc2026-03-09
06978880220051ZarcT0.02/40#/200pc2026-03-09
06978880220068ZarcT0.02/15#-40#/assorted/200pc2026-03-09
06978880220075ZarcT0.02/45#/200pc2026-03-09
06978880220082ZarcT0.02/50#/200pc2026-03-09
06978880220099ZarcT0.02/55#/200pc2026-03-09
06978880220105ZarcT0.02/60#/200pc2026-03-09
06978880220112ZarcT0.02/70#/200pc2026-03-09
06978880220129ZarcT0.02/80#/200pc2026-03-09
06978880220136ZarcT0.02/45#-80#/assorted/200pc2026-03-09
06978880220143ZarcT0.02/90#/100pc2026-03-09
06978880220150ZarcT0.02/100#/100pc2026-03-09
06978880220167ZarcT0.02/90#-140#/assorted/100pc2026-03-09
06978880220174ZarcT0.04/15#/100pc2026-03-09
06978880220181ZarcT0.04/20#/100pc2026-03-09
06978880220198ZarcT0.04/25#/100pc2026-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978880220006ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220013ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220020ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220037ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220044ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220051ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220068ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220075ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220082ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220099ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220105ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220112ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220129ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220136ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220143ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220150ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220167ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220174ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220181ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220198ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220204ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220211ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220228ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220235ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220242ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220259ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220266ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220273ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220280ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220297ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09