FDA.report

MARK3

Primary DI
D7962103CASE1
Brand
MARK3
Company
CARGUS INTERNATIONAL, INC
Model
2103case
Device description
Air Water Syringe Sleeves Clear 2-1/2" x 10" 500pcs/bx - 36bxs/cs - MARK3
Published
2016-12-07
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
D7962103CASE1PrimaryHIBCC0
D7962103Unit of UseHIBCC0

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
36
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
D125100B2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125100C2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251012Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251022Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251032Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125104L2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125104S2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251062Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251072Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251082Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251092Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251112Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251122Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251132Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251142Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251182Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251192Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125123L2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125123M2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125123S2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125123SS2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125123XL2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251252Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125125SS2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251282Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251292Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125133L2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125133S2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125135L2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125135S2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22