FDA.reportPublic FDA data

Burkhart Aspriating Syringe - Cook Waite Style

Primary DI
00815878020667
Brand
Burkhart Aspriating Syringe - Cook Waite Style
Company
BURKHART DENTAL SUPPLY CO., THE
Model
72720818
Published
2017-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJISyringe, Cartridge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJISyringe, CartridgeDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815878020667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815878020667008158780206678158780206670815878020667

GMDN Terms#

Term, Definition table
TermDefinition
Syringe-accepting percutaneous/submucosal fluid injector, manual, professionalA hand-held, manually-powered mechanical device intended for use by a healthcare professional to accept a syringe (not included) for administering a percutaneous (e.g., intramuscular, subcutaneous) and/or submucosal injection of a medical fluid (e.g., medication, vaccine) to a patient; it is not dedicated to dental or intravenous applications. The device is typically a spring-loaded mechanical assembly in the form of a pistol or cylinder; the pharmaceutical is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(855) 562-8176customerservice@burkhartdental.com

Regulatory Flags#

DUNS number
027532357
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815878020674Burkhart Aspirating Syringe - Astra Style727208192017-06-30
00810052610306Burkhart Dental Supply727218402024-01-15
00810052610313Burkhart Dental Supply727218412024-01-15
00810052610320Burkhart Dental Supply727218422024-01-15
00810052610337Burkhart Dental Supply727218432024-01-15
00810052610696Burkhart Dental Supply727218442024-01-15
00815878020100Burkhart Select Multivariable Sterilization Pouch 5 1/4X10 (200)727206602016-09-16
00815878020117Burkhart Select Multivariable Sterilization Pouch 2 3/4 X 9 (200)727206612016-09-16
00815878020124Burkhart Select Multivariable Sterilezation Pouch 3 1/2 x 5 1/4 (200)727206632016-09-16
00815878020131Burkhart Select Multivariable Sterilization Pouch 3-1/2 x 9 (200)727206622016-09-16
00815878021053"Burkhart Sterile Pouches 7-1/2"" x 13"" (200)"727208432018-04-13
00815878027628Burkhart Dental Supply727220272024-05-07
00815878027642Burkhart Dental Supply727220292024-05-07
00854212006165Burkhart Etching Gel 2-5ml Syringes 37.5% w/20-22ga Tips727204242016-09-16
00815878028397Burkhart Dental Supply727209812024-12-06
00815878028403Burkhart Dental Supply727209822024-12-06
00815878028410Burkhart Dental Supply727209832024-12-06
00815878028427Burkhart Dental Supply727209842024-12-06
00815878028441Burkhart Dental Supply727209862021-05-14
00854212006004"Burkhart 3-0 Chromic Gut Suture 18"", C-6 Needle"727207652016-03-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G879100297B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
G879100297C0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
G8791003020DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
G879100302B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
G8791003130DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
G879100313B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
G87910032910DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
03760349801054QUICKSLEEPER 5C_A2 US/CADENTALHITECEJI2025-12-22
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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
08800075614360OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-22
08800075614414OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-22
00840326421765AstekYoung Innovations, Inc.EJI2023-12-01
00840326421772AstekYoung Innovations, Inc.EJI2023-12-01