FDA.reportPublic FDA data

MEDICOM SAFEJET

Primary DI
00686864057277
Brand
MEDICOM SAFEJET
Company
AMD Medicom Inc
Model
1007074
Catalog number
1007074
Device description
MEDICOM SAFEJET DISPOSABLE AIR/WATER SYRINGE TIPS - White
Published
2021-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ECBUnit, Syringe, Air And/Or Water

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECBUnit, Syringe, Air And/Or WaterDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20686864057271PackageGS112In Commercial Distribution
10686864057274PrimaryGS10
00686864057277Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2068686405727120686864057271
1068686405727410686864057274
00686864057277006868640572776868640572770686864057277

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery system irrigation handpieceA hand-held device that is used to regulate and direct a stream of pressurized, warmed water and/or air for the purpose of irrigating/clearing debris from the field of operation in the oral cavity during restorative or operative dental procedures. It is fitted with a long syringe-like nozzle that is activated by the user, typically through push-type controls. This device, also commonly known as a three-way or a Triplex syringe, is typically a component of a dental delivery system from which the air and water is supplied. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-514-636-6262mkansou@medicom.ca

Regulatory Flags#

DUNS number
256880576
Device count
250
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20686864061933MEDICOM ASSUREMASK VALIANT205915-B205915-B2026-03-17
20686864061940MEDICOM ASSUREMASK VALIANT205915-C205915-C2026-03-17
20686864060943MEDICOM DENTICARE 10067100672026-02-25
20686864060950MEDICOM DENTICARE 10068100682026-02-25
D8304405062PROFESSIONAL'S CHOICE4405064405062026-02-10
D8305514332MEDICOM5514335514332026-02-10
20686864061643MEDICOM2244152244152025-11-20
20686864061650MEDICOM224415.001224415.0012025-11-20
20686864061735MEDICOM224415.002224415.0022025-11-20
20686864061469Medicom SafeBasics2101-CHUS2101-CHUS2025-05-13
20686864061476AMD-RitmedA2100-CHUSA2100-CHUS2025-05-13
20686864061483AMD-RitmedA2101-CHUSA2101-CHUS2025-05-13
20686864061490AMD-RitmedA2103-CHUSA2103-CHUS2025-05-13
20686864051538AMD-RITMEDA60044A600442019-01-13
20686864061452Medicom SafeBasics2100-CHUS2100-CHUS2025-05-06
20686864061377Medicom AssureTouch9940-A9940-A2025-04-24
20686864061384Medicom AssureTouch9940-B9940-B2025-04-24
00686864061397Medicom AssureTouch9940-C9940-C2025-04-24
20686864061407Medicom AssureTouch9940-D9940-D2025-04-24
00686864061410Medicom AssureTouch9940-E9940-E2025-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810208581269NuCareNuCare LLCECB2026-02-03
10810208581266NuCareNuCare LLCECB2026-02-03
20810208581263NuCareNuCare LLCECB2026-02-03
E89627160SCHWERTA. Schweickhardt GmbH & Co. KGECB2025-04-07
03760243009907Classic by RISKONTROLPRODUITS DENTAIRES PIERRE ROLLANECB2025-04-01
10840326423674AstekYoung Innovations, Inc.ECB2025-02-07
00810021436722DCIDCI International, LLCECB2024-12-13
00810021436739DCIDCI International, LLCECB2024-12-13
00810021436746DCIDCI International, LLCECB2024-12-13
00850048528864Amtouch Air/Water Syringe TipsAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.ECB2024-10-08
00850048528901Amtouch Air/Water Syringe TipsAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.ECB2024-10-08
00850048528918Amtouch Air/Water Syringe TipsAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.ECB2024-10-08
00810021433783DCIDCI International, LLCECB2024-08-02
D930205010020JMUJMU DENTAL, INCECB2024-06-27
00810021435947DCIDCI International, LLCECB2024-05-24
20810021435958DCIDCI International, LLCECB2024-05-24
D248B1619B0DurationHAGER WORLDWIDE, INC.ECB2024-05-20
D248B16280Uni-TipHAGER WORLDWIDE, INC.ECB2024-05-20
E8962702090SCHWERTA. Schweickhardt GmbH & Co. KGECB2024-05-16
00810021434216DCIDCI International, LLCECB2024-05-13
00810021435466DCIDCI International, LLCECB2024-05-13
00810021435534DCIDCI International, LLCECB2024-05-13
00810021435541DCIDCI International, LLCECB2024-05-13
00810021435589DCIDCI International, LLCECB2024-05-13
00810021435602DCIDCI International, LLCECB2024-05-13
00810021435633DCIDCI International, LLCECB2024-05-13
00810021435640DCIDCI International, LLCECB2024-05-13
00810021435664DCIDCI International, LLCECB2024-05-13
00810021435671DCIDCI International, LLCECB2024-05-13
00810021435688DCIDCI International, LLCECB2024-05-13