FDA.report

MARK3

Primary DI
D79621031
Brand
MARK3
Company
CARGUS INTERNATIONAL, INC
Model
2103
Device description
Air Water Syringe Sleeves Clear 2-1/2" x 10" 500/bx. MARK3
Published
2016-12-01
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

Related Records

Product Codes

CodeName
PEMDental Barriers And Sleeves

Product Code Classifications

CodeDeviceSpecialtyClass
PEMDental Barriers And SleevesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D79621031PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental bibA non-sterile device intended to be worn by a patient during a dental examination or treatment procedure to function as a barrier to soiling and cross-contamination. It typically consists of a shaped piece of natural and/or synthetic material intended to be fastened around the neck and cover the front side of the upper body. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
096191093
Device count
1
DM exempt
false
Premarket exempt
false
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
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850014374983MARK3®597259722026-02-05
00850014374990MARK3®597459742026-02-05
D7969003MARK390032025-03-06
D7969001MARK390012025-02-28
00850014374532MARK3855-016XC855-016XC2024-07-24
00850014374549MARK3848-018XC848-018XC2024-07-24
00850014374556MARK3652S-018XC652S-018XC2024-07-24
00850014374563MARK3655S-018XC655S-018XC2024-07-24
00850014374570MARK3855-018C855-018C2024-07-24
00850014374587MARK3652S-017XC652S-017XC2024-07-24
D79616501MARK3165016502024-07-22
D79616521MARK3165216522024-07-22
D79616541MARK3165416542024-07-22
D79614260MARK3142614262023-11-15
D7961426X0MARK31426X1426X2023-11-15
D79614300MARK3143014302023-11-15
D79614320MARK3143214322023-11-15
D79614330MARK3143314332023-11-15
D79619112MARK3191119112023-11-09
D79619122MARK3191219122023-11-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B9764488101OptiClear SleevesMinitube ABPEM2026-02-13
B9764488081OptiClear SleevesMinitube ABPEM2026-02-13
06430035873357COMFORT OCCLUSAL 4C ACCESSORY KITPaloDEx Group OyPEM2025-12-23
06430035873388OCCLUSAL 4C REFILL KITPaloDEx Group OyPEM2025-12-23
20618125192308CarinaTIDI PRODUCTS, LLCPEM2025-09-22
10618125187123VALOTIDI PRODUCTS, LLCPEM2025-08-29
10618125187130VALOTIDI PRODUCTS, LLCPEM2025-08-29
10618125187147VALOTIDI PRODUCTS, LLCPEM2025-08-29
80618125188716VALOTIDI PRODUCTS, LLCPEM2025-08-29
80618125188723VALOTIDI PRODUCTS, LLCPEM2025-08-29
80618125188730VALOTIDI PRODUCTS, LLCPEM2025-08-29
10618125189950VALOTIDI PRODUCTS, LLCPEM2025-08-29
80618125190177VALOTIDI PRODUCTS, LLCPEM2025-08-29
10618125190185VALOTIDI PRODUCTS, LLCPEM2025-08-29
00840456214237JMUJMU DENTAL, INCPEM2025-07-15
00840456202609JMUJMU DENTAL, INCPEM2025-06-17
00840456202616JMUJMU DENTAL, INCPEM2025-06-17
00840456207116JMUJMU DENTAL, INCPEM2025-06-17
00840456209042JMUJMU DENTAL, INCPEM2025-06-17
00840456209059JMUJMU DENTAL, INCPEM2025-06-17
00840456209066JMUJMU DENTAL, INCPEM2025-06-17
07350069421562C20 Intraoral Protective SheathsMinitube ABPEM2025-04-01
07350069420572C20 Intraoral Protective SheathsMinitube ABPEM2025-04-01
30665973031812UnipackDukal LLCPEM2025-03-20
30665973031829UnipackDukal LLCPEM2025-03-20
30665973031836UnipackDukal LLCPEM2025-03-20
00850058951386Amtouch Barrier EnvelopesAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.PEM2024-10-08
00850058951393Amtouch Barrier EnvelopesAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.PEM2024-10-08
00850058951409Amtouch Barrier EnvelopesAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.PEM2024-10-08
00850058951416Amtouch Barrier EnvelopesAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.PEM2024-10-08