FDA.report

Absorbant Paper Points, 15

Primary DI
08806387828457
Brand
Absorbant Paper Points, 15
Company
Meta Biomed Co., Ltd.
Model
2845
Device description
Absorbent Paper Points, 02 Taper 15, 200 Points, P 21
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

Related Records

Product Codes

CodeName
EKNPoint, Paper, Endodontic

Product Code Classifications

CodeDeviceSpecialtyClass
EKNPoint, Paper, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08806387828457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08806387828457088063878284578806387828457

GMDN Terms

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
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

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08806387814658MX 02-4014652025-08-26
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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

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06978880220266ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
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06978880220297ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09