FDA.reportPublic FDA data

Absorbent Paper Points, LM-10

Primary DI
08806387823988
Brand
Absorbent Paper Points, LM-10
Company
Meta Biomed Co., Ltd.
Model
2398
Device description
Absorbent Paper Points, Length Marked 02 Taper 10, 120 Points, P 71
Published
2022-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
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
08806387823988PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806387823988088063878239888806387823988

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
Radiation Sterilization

Regulatory Flags#

DUNS number
688322841
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806387814603MX 02-1514602025-08-26
08806387814610MX 02-2014612025-08-26
08806387814627MX 02-2514622025-08-26
08806387814634MX 02-3014632025-08-26
08806387814641MX 02-3514642025-08-26
08806387814658MX 02-4014652025-08-26
08806387814665MX 04-1514662025-08-26
08806387814672MX 04-2014672025-08-26
08806387814689MX 04-2514682025-08-26
08806387814696MX 04-3014692025-08-26
08806387814702MX 04-3514702025-08-26
08806387814719MX 04-4014712025-08-26
08806387814726MX 06-1514722025-08-26
08806387814733MX 06-2014732025-08-26
08806387814740MX 06-2514742025-08-26
08806387814757MX 06-3014752025-08-26
08806387814764MX 06-3514762025-08-26
08806387814771MX 06-4014772025-08-26
08806387814788MG 02-15 LM14782025-08-26
08806387814795MG 02-20 LM14792025-08-26

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