FDA.report

Darby Dental Supply, LLC

Primary DI
00889813055366
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
0758512
Catalog number
0758512
Device description
NITI OPEN COIL SPRING .012X.030 7"L
Published
2021-11-12
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
true

Related Records

Contact Domains

Product Codes

CodeName
ECOSPRING, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
ECOSpring, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889813055366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813055366008898130553668898130553660889813055366

GMDN Terms

TermDefinition
Orthodontic wireA thread or slender rod of metal (e.g., stainless steel, precious metal) incorporated into an orthodontic appliance, typically as part of an orthodontic appliance system. It is available in various dimensions and grades, and is used to exert pressure on teeth in order to alter their position. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(516)688-6800Robyn.livingston@darby.com

Regulatory Flags

DUNS number
825137818
Device count
1
DM exempt
true
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
false
Sterilization required before use
false

Other Devices From This Company

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10889813067809Darby Dental Supply, LLC95531462025-07-02
10889813067816Darby Dental Supply, LLC95531472025-07-02
10889813067823Darby Dental Supply, LLC95531482025-07-02

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