FDA.reportPublic FDA data

Needle Adapter

Primary DI
00609960001272
Brand
Needle Adapter
Company
DERMATOLOGIC LAB AND SUPPLY, INC.
Model
ADAPT/DNTL
Catalog number
ADAPT/DNTL
Device description
ADAPTER, FOR DENTAL NEEDLE, 3/32in X 1 1/8in LONG SHAFT
Published
2018-07-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001029000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001029000GEIGER NEEDLE ADAPTER, MODEL 406Geiger Medical Technologies, Inc.2000-05-23GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00609960001272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00609960001272006099600012726099600012720609960001272

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical electrode extensionA long, thin electrical conductor intended to extend the length of a monopolar electrosurgical electrode during an open surgical procedure. The electrode is fixed to the distal end of the device and the proximal end is attached to an electrosurgical handpiece. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
021628771
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00609960000190Delasco 734 Handpiece734/H2016-05-13
00609960000251Delasco Electricator26000260002016-05-19
00609960000268ELECTRICATOR HANDPIECE26300263002016-05-19
10609960000012Delasco Biopsy SutureBDL-40B2015-11-02
10609960000029Delasco Biopsy SutureBDL-50B2015-11-02
10609960000036Delasco Biopsy SutureBDL-60B2015-11-02
10609960000043Delasco Biopsy SutureMS-40B2015-11-02
10609960000050Delasco Biopsy SutureMS-50B2015-11-02
10609960000067Delasco Biopsy SutureMS-60B2015-11-02
00609960001326Smoke Evacuator FilterEV-I/REV-I/R2020-09-30
00609960001302SaftEvacEV-IEV-I2020-09-16
00609960001296Delasco SaftEvac FilterEV/XEV/X2020-08-04
00609960000282Delasco Electricator Reusable Patient Plate26900269002016-06-15
00609960001289Segal ElectrodeSE/G1SE/G2019-12-31
10609960000135ElectroTipsET-1012016-05-13
10609960000142ElectroTipsET-1022016-05-13
10609960000159ElectroTipsET-1032016-05-13
10609960000166ElectroTipsET-1042016-05-13
10609960000173Electrolite262002016-05-13
10609960000180Electrolite26200S2016-05-13

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Primary DI, Brand, Company table
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08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
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