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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDGEI2026-10-20
00190776435288MillenniumAvalign Technologies, Inc.GEI2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
00860016247000Super PencilRF KINETICS LLCGEI2026-10-17
00860016247017Super PencilRF KINETICS LLCGEI2026-10-17
00860016247024Super PencilRF KINETICS LLCGEI2026-10-17
00860016247031Super PencilRF KINETICS LLCGEI2026-10-17
00841019124017KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124024KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124048KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124079KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124086KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124093KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124109KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124116KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124123KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124130KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
10381780533276Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
10381780533283Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
00190776435028MillenniumAvalign Technologies, Inc.GEI2026-10-14
00190776434878MillenniumAvalign Technologies, Inc.GEI2026-10-13