FDA.report

SCHWERT

Primary DI
E8964960490
Brand
SCHWERT
Company
A. Schweickhardt GmbH & Co. KG
Model
4960-49
Catalog number
4960-49
Device description
Scaler and band seater, serrated 16,5cm
Published
2023-03-06
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

Contact Domains

Product Codes

CodeName
ECSPUSHER, BAND, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
ECSPusher, Band, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E8964960490PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthodontic appliance dimension gaugeA dental instrument intended to be used for accurate measurement of the dimensions of an orthodontic appliance (e.g., orthodontic bracket height) especially as it relates to patient oral anatomy during the fitting of the appliance (e.g., determining distance from the incisal edge to an orthodontic bracket locator blade). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+49746498910700contact@schwert.com

Regulatory Flags

DUNS number
341195628
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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