FDA.report

Expandex™

Primary DI
10810000526786
Brand
Expandex™
Company
PARKELL, INC.
Model
S227
Catalog number
S227
Device description
Child Expandex™ (Pkg. of 2 pcs.)
Published
2019-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EIGRetractor, All Types

Product Code Classifications

CodeDeviceSpecialtyClass
EIGRetractor, All TypesDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810000526786PrimaryGS10
00810000526789Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081000052678610810000526786
00810000526789008100005267898100005267890810000526789

GMDN Terms

TermDefinition
Dental dry field kitA collection of devices and supplies used in orthodontic and restorative dentistry to maintain a dry oral cavity for treatment procedures. It provides the operator with easy access to the field of operation by holding the mouth open, displacing the tongue, and removing saliva during various procedures (e.g., bonding orthodontic brackets, bleaching, applying veneers or pit and fissure sealants, posterior restorations). It typically consists of bite blocks, pad extenders, suction tips of varying sizes, and tubing that connects to a suction system. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
631-249-1134customerservice@parkell.com

Regulatory Flags

DUNS number
009900424
Device count
2
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
true

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