FDA.report

Absorbent Paper Points, LM-60

Primary DI
08806387828396
Brand
Absorbent Paper Points, LM-60
Company
Meta Biomed Co., Ltd.
Model
2839
Device description
Absorbent Paper Points, Length Marked 02 Taper 60, 300 Points, P 31R
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
08806387828396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08806387828396088063878283968806387828396

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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08806387814788MG 02-15 LM14782025-08-26
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