FDA.report

Darby Dental Supply, LLC

Primary DI
00889813039366
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
9518815
Catalog number
9518815
Device description
RONGEURS NO 4A DARBY
Published
2020-05-26
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
EKDINSTRUMENT, CUTTING, OPERATIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EKDInstrument, Cutting, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889813039366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813039366008898130393668898130393660889813039366

GMDN Terms

TermDefinition
Dental rongeurA strongly constructed dental instrument that is used in the removal of the sharp edges of the alveolar crest of the bone following tooth extraction. It has a forceps or pliers-like design terminating at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws that bite (cut) through the bone tissue. It is made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
825137818
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
false
Sterilization required before use
false

Other Devices From This Company

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07897990302312MICROCUTTDV DENTAL LTDAEKD2025-02-28
07897990302329MICROCUTTDV DENTAL LTDAEKD2025-02-28
07897990302336MICROCUTTDV DENTAL LTDAEKD2025-02-28
07897990332401MICROCUTTDV DENTAL LTDAEKD2025-02-28
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10889950110352Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEKD2023-06-27
00190776362522MillenniumAVALIGN TECHNOLOGIES, INC.EKD2023-02-22
E8963438100SCHWERTA. Schweickhardt GmbH & Co. KGEKD2023-02-22
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E8963439130SCHWERTA. Schweickhardt GmbH & Co. KGEKD2023-02-22
00887919684213Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-08
00887919198635Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-07
00887919198680Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-07
00887919198727Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-07
00887919198987Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-07
00887919199892Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-07
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07898506811106QuinelatoSchobell Industrial LtdaEKD2022-11-28
07898506839315QuinelatoSchobell Industrial LtdaEKD2022-11-28
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