FDA.report

PDT, Inc.

Primary DI
00813677022646
Brand
PDT, Inc.
Company
PDT, INC.
Model
T100 Caewood-Minnesota Retractor
Catalog number
T100
Device description
T100 Caewood-Minnesota Retractor
Published
2024-06-27
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
false

Related Records

Product Codes

CodeName
EIFAccessories, Retractor, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813677022646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677022646008136770226468136770226460813677022646

GMDN Terms

TermDefinition
Hand-held dental retractorA hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. It is typically a metallic device and includes a shaped/hooked blade with a handle/holding portion. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Regulatory Flags

DUNS number
125850144
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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