FDA.reportPublic FDA data

SAFETY WAND Handpiece

Primary DI
20618874000176
Brand
SAFETY WAND Handpiece
Company
Milestone Scientific Inc.
Model
WA-2040 SAF-305
Device description
SAFETY WAND Handpiece with needle
Published
2018-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EJISyringe, Cartridge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJISyringe, CartridgeDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023722000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023722000SAFETYWAND DISPOSABLE HANDPIECESpintech, Inc.2003-09-02EJI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20618874000176PrimaryGS10
00618874000176Unit of UseGS10
00618874433055Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061887400017620618874000176
00618874000176006188740001766188740001760618874000176
00618874433055006188744330556188744330550618874433055

GMDN Terms#

Term, Definition table
TermDefinition
Dental computer assisted anaesthesia injection handpieceA sterile, hand-held component of a dental computer assisted local anaesthesia delivery system intended to accurately administer a local anaesthetic agent within the oral cavity for improved analgesic localization and pain reduction. It is typically designed in the form of a pen or wand connected to a dental computer assisted anaesthesia injection unit via tubing, and used in conjunction with a dental anaesthesia cartridge and a needle. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006891188
Device count
480
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00618874601133CathCheck Disposable KitEPI-6011-032025-01-17
00618874601034CathCheck Disposable Kit (Pre-assembled)EPI-6010-032023-06-14
00618874601102Epidural Disposable KitEPI-60112023-06-14
00618874610012Epidural Disposable Box EPI-6100-012023-06-14
00618874610036CathCheck Disposable KitEPI-6100-032023-06-14
00618874999988Epidural Trainer Disposable KitEPI-6510T 2023-06-14
00618874999995CompuFlo Epidural Trainer 110V/220VEPI-6500T2023-06-14
00618874112042CompuDent STA Drive UnitSTA-52202023-06-13
00618874116033CompuFlo Epidural Computer Controlled Anesthesia SystemEPI-6000-1102023-06-13
00618874116040CompuFlo Epidural Computer Controlled Anesthesia SystemEPI-6000-2202023-06-13
00618874601010Epidural Disposable Kit EPI-6010-012023-06-13
00618874112035CompuDent-STA™ Drive UnitSTA-51102023-06-12
00618874116101Epidural Disposable KitEPI-61002022-09-30
00618874000219CompuFlo EpiduralEPI-6000-1102022-09-30
20618874000220Epidural Disposable KitEPI-60102022-09-30
10618874000025the Wand STA HandpieceSTA-5050A2018-01-26
10618874000032the Wand STA HandpieceSTA-5050-27252018-01-26
10618874000049the Wand STA HandpieceSTA-5050-3012018-01-26
10618874000056the Wand STA HandpieceSTA-5050-3052018-01-26
10618874000063Safety Wand STA HandpieceSTA-5040ASAF2018-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760349801054QUICKSLEEPER 5C_A2 US/CADENTALHITECEJI2025-12-22
00840326422670AstekYoung Innovations, Inc.EJI2025-10-10
00840326423691AstekYoung Innovations, Inc.EJI2025-10-10
00840326422687AstekYoung Innovations, Inc.EJI2025-05-27
00840326423707AstekYoung Innovations, Inc.EJI2025-05-27
00840326422663AstekYoung Innovations, Inc.EJI2025-05-27
00840326423684AstekYoung Innovations, Inc.EJI2025-05-27
00840326423721AstekYoung Innovations, Inc.EJI2025-05-27
05713513001185ASPIJECT Active CompactRønvig Dental Manufacturing A/SEJI2025-02-27
05060212052117Dental Syringe 85mm, for 2.2ml vialDTR MEDICAL LIMITEDEJI2024-10-11
05060212052124Dental Syringe Long 115mm, for 2.2ml vialDTR MEDICAL LIMITEDEJI2024-10-11
05060212057518Dental Syringe 85mm, for 2.2ml vialDTR MEDICAL LIMITEDEJI2024-10-11
05060212057525Dental Syringe Long 115mm, for 2.2ml vialDTR MEDICAL LIMITEDEJI2024-10-11
00813677022882PDT, Inc.PDT, INC.EJI2024-07-01
00813677022905PDT, Inc.PDT, INC.EJI2024-07-01
00813677022899PDT, Inc.PDT, INC.EJI2024-06-27
08800075607799OSUNG MNDOSUNG MND Co., Ltd.EJI2024-03-05
08800075614391OSUNG MNDOSUNG MND Co., Ltd.EJI2024-03-05
08800075614407OSUNG MNDOSUNG MND Co., Ltd.EJI2024-03-05
08800075614421OSUNG MNDOSUNG MND Co., Ltd.EJI2024-03-05
08800075624994OSUNG MNDOSUNG MND Co., Ltd.EJI2024-03-05
08800075607812OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-23
08800075626332OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-23
08800075626349OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-23
08800075626356OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-23
08800075614360OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-22
08800075614414OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-22
08800053042093DENOPSDENTIS CO. ,LTDEJI2024-01-23
00840326421765AstekYoung Innovations, Inc.EJI2023-12-01
00840326421772AstekYoung Innovations, Inc.EJI2023-12-01