FDA.reportPublic FDA data

Sharps Crate

Primary DI
00616784463131
Brand
Sharps Crate
Company
DYNAREX CORPORATION
Model
4631
Published
2017-06-16
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
true

Product Codes#

Code, Name table
CodeName
MMKContainer, Sharps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMKContainer, SharpsGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082042000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082042000GONGDONG DISPOSABLE SHARP CONTAINERZhejiang Gongdong Medical Plastic Factory2008-09-03MMK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784463131PackageGS140In Commercial Distribution
00616784463117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784463131006167844631316167844631310616784463131
00616784463117006167844631176167844631170616784463117

GMDN Terms#

Term, Definition table
TermDefinition
Sharps containerA device designed as a container to allow the safe deposit and collection of biologically or chemically contaminated used sharps; this includes needles, lancets, scalpel blades, cannulae, or other devices that present a hazard to a healthcare worker or patient if they were to inadvertently have bodily contact with the device and cause themselves an injury. This container is typically designed to be puncture resistant, leak-proof, and closable (usually having a lid that cannot be reopened once closed) and is identified with the universal biohazard symbol on its labelling. It is disposed of when filled to the recommended level, typically be incineration.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117341913Steel Button Folding Walker, Adult, With 5" Wheel, 32" - 39"10170-42026-08-03
00840117338067Resp-O2 M24 Oxygen E-Cylinder With CGA 870 Toggle Valve, 4.55 L36390-T2024-07-25
00840117338135Resp-O2 M15 Oxygen Standard D-Cylinder 2.89 L, With CGA 870 Post Valve363942024-07-25
00840117326156Resp-O2 M9 Oxygen C-Cylinder 1.7L363922023-12-29
00840117327511Resp-O2 M6 Oxygen B-Cylinder,1L With CGA870 Post Valve363932023-12-29
00840117327528Resp-O2 M15 Oxygen D-Cylinder, 2.9 L With CGA 870 Post Valve363912023-12-29
00840117326125Resp-O2 M24 Oxygen E-Cylinder, With CGA870 Post Valve363902023-03-24
00840117310162Resp-O2 Fingertip Pulse Oximeter, For Adult Use364002021-12-22
00840117341241Aluminum Crutches, Child, 4'0" - 4'6"10100-82026-07-31
00840117341258Aluminum Crutches, Youth, 4'6" - 5'2"10101-82026-07-31
00840117341265Aluminum Crutches, Adult, 5'2" - 5'10"10102-82026-07-31
00840117341272Aluminum Crutches, Tall, 5'10" - 6'6"10103-82026-07-31
00840117341357Forearm Crutches, Youth, 4'2" - 5'2"10110-62026-07-31
00840117341364Forearm Crutches, Adult, 5'0" - 6'2"10111-62026-07-31
00840117341371Forearm Crutches, Tall, 5'10" - 6'6"10112-62026-07-31
00840117346253Pill Crusher Pouches with Round Corners4210R2026-07-31
00840117349551Drape Sheets, Polypropylene/Polyethylene 2-ply, Black, 40" x 90" (101.6 cm x 22881562026-07-31
00840117350069Pillow Cases, Polypropylene/Polyethylene 2-ply, Black, 21" x 30"81672026-07-31
00840117351684Universal Catheterization Procedure Trays with 2000 mL Anti-Reflux Drainage Bag50032026-07-31
00840117351875Resp-O2 Single Suction Catheters, Pediatric Graduated Catheter32000S2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253004243MonojectCardinal Health 200, LLCMMK2026-08-03
10192253004250MonojectCardinal Health 200, LLCMMK2026-08-03
10192253004304MonojectCardinal Health 200, LLCMMK2026-08-03
10192253004458MonojectCardinal Health 200, LLCMMK2026-07-31
10192253004465MonojectCardinal Health 200, LLCMMK2026-07-31
10192253004472MonojectCardinal Health 200, LLCMMK2026-07-31
10192253004915MonojectCardinal Health 200, LLCMMK2026-07-31
10192253005295MonojectCardinal Health 200, LLCMMK2026-07-31
10192253005622MonojectCardinal Health 200, LLCMMK2026-07-31
10192253004205MonojectCardinal Health 200, LLCMMK2026-07-13
10192253004410MonojectCardinal Health 200, LLCMMK2026-07-13
10192253004540MonojectCardinal Health 200, LLCMMK2026-07-13
10192253004588MonojectCardinal Health 200, LLCMMK2026-07-13
10192253004625SharpSafetyCardinal Health 200, LLCMMK2026-07-13
10192253004885MonojectCardinal Health 200, LLCMMK2026-07-13
00827989008250SharpSafetyHealth Care Logistics, Inc.MMK2026-07-10
10192253004649MonojectCardinal Health 200, LLCMMK2026-07-09
10192253004656MonojectCardinal Health 200, LLCMMK2026-07-09
10192253004663MonojectCardinal Health 200, LLCMMK2026-07-09
10192253004700MonojectCardinal Health 200, LLCMMK2026-07-09
MHC18601502EasyTouchMHC MEDICAL PRODUCTS, LLCMMK2026-06-23
MHC18601552EasyTouchMHC MEDICAL PRODUCTS, LLCMMK2026-06-23
MHC18602502EasyTouchMHC MEDICAL PRODUCTS, LLCMMK2026-06-23
MHC18602552EasyTouchMHC MEDICAL PRODUCTS, LLCMMK2026-06-23
00768627017275Norco Sharps ContainerNORTH COAST MEDICAL, INC.MMK2026-06-01
10192253005660NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005684NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005691NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005707NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005714NOVAPLUSCardinal Health 200, LLCMMK2026-05-20