FDA.report

Darby Dental Supply, LLC

Primary DI
00889813044827
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
9532355
Catalog number
9532355
Device description
NEEDLES PLASTIC HUB 27G LONG
Published
2022-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DZMNEEDLE, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
DZMNeedle, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889813044834PrimaryGS10
00889813044827Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813044834008898130448348898130448340889813044834
00889813044827008898130448278898130448270889813044827

GMDN Terms

TermDefinition
Dental syringe needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument with an integral hub, typically intended to be attached to a dental cartridge syringe for the injection of local anaesthetics. This is a single-use device.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
825137818
Device count
100
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
true
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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10889813067731Darby Dental Supply, LLC95531402025-07-02
10889813067755Darby Dental Supply, LLC95531412025-07-02
10889813067762Darby Dental Supply, LLC95531422025-07-02
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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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50192253037430MonojectCardinal Health 200, LLCDZM2026-02-10
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