FDA.report

Mirror Cotton Holders

Primary DI
00723896010075
Brand
Mirror Cotton Holders
Company
PRACTICON, INC.
Model
1604-P01
Catalog number
70-42625
Device description
snap onto size 4 and size 5 mouth mirrors and feature twin tabs to keep both lingual and buccal cotton rolls in place during lower posterior procedures. Easily reversible for left or right quadrants. 100 single-use, disposable holders per bag. Not for use with Zirc mouth mirrors.
Published
2018-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EAXMirror, Mouth

Product Code Classifications

CodeDeviceSpecialtyClass
EAXMirror, MouthDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00723896010075PackageGS1120In Commercial Distribution
00723896010068PrimaryGS10
00723896008225Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00723896010075007238960100757238960100750723896010075
00723896010068007238960100687238960100680723896010068
00723896008225007238960082257238960082250723896008225

GMDN Terms

TermDefinition
Dental cotton rollA non-sterile designed as an absorbent, non-sterile mass of cotton or man-made fibres formed as a small, short, hard-packed cylinder (a roll) that is used as a saliva absorber and intended to absorb moisture from the oral cavity during dental procedures. It may also be used as a packing between the lip/cheek and the gum to give better examination/operative exposure. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
119193803
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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