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
00840117352339Hypodermic Needle, Non-Safety, 20G, 3/4" needles69802019-05-06
00616784910017CurPro Nylon Suture, Black Monofilament, Nonabsorbable, Synthetic91002016-09-24
00616784910116CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91012016-09-24
00616784910215CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91022016-09-24
00616784910314CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91032016-09-24
00616784910413CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91042016-09-24
00616784910611CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91062016-09-24
00616784910710CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91072016-09-24
00616784913018Polyglycolic Acid (PGA) Sutures, Coated Synthetic Absorbable, Violet, Braided91302016-09-24
00616784913117CurPro Polyglycolic Acid (PGA) Sutures, Coated Synthetic Absorbable, Violet91312016-09-24
00616784914213CurPro Silk Sutures Natural Material, Braided Black, Nonabsorbable91422016-09-24
00616784914312CurPro Silk Sutures Natural Material, Braided Black, Nonabsorbable91432016-09-24
00840117325920Bari + Max Bariatric Steel Crutches, Tall Adult, 1000 lb. weight capacity,101052023-01-11
00840117325937Bari + Max Bariatric Steel Crutches, Adult, 1000 lb. Weight Capacity, 1 Pair101062023-01-11
00616784010113Aluminum Crutches - Youth101012019-09-30
00616784010212Aluminum Crutches - Adult101022019-09-30
00616784010311Aluminum Crutches - Tall101032019-09-30
00616784010410DMECARE Solutions, Universal Crutches101042019-09-26
00840117352124AloeSkin, Nitrile Examination Gloves, With Vitamin E, Powder-Free, Rose Gloves67212019-11-25
00840117352148AloeSkin, Nitrile Examination Gloves, With Vitamin E, Powder-Free, Rose Gloves67222019-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10192253005721NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005738NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005745NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005752NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005769NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10197344118496MEDLINEMEDLINE INDUSTRIES, INC.MMK2024-11-28
16971292007088AUVONShenzhen Yuwen E-Commerce Co., Ltd.MMK2024-08-13
16971292007095AUVONShenzhen Yuwen E-Commerce Co., Ltd.MMK2024-08-13
10884521023192MonojectCardinal Health 200, LLCMMK2023-12-21
10884521023239MonojectCardinal Health 200, LLCMMK2023-12-21
20884521023113MonojectCardinal Health 200, LLCMMK2023-12-21
16947462492404GongdongZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.MMK2023-09-07
10884521141407SharpSafetyCardinal Health, Inc.MMK2023-08-23
09337363001834BladeFlask EVOQLICKSMART PTY LTDMMK2023-06-23
09337363001841BladeFlask EVOQLICKSMART PTY LTDMMK2023-06-23
10884521023062Sharps-A-GatorCardinal Health, Inc.MMK2023-02-06
10884521023338SharpSafetyCardinal Health, Inc.MMK2023-02-06
20884521076805Sharps-A-GatorCardinal Health, Inc.MMK2023-02-06
10080196282654MedlineMEDLINE INDUSTRIES, INC.MMK2022-11-30
10612479209340McKessonMCKESSON MEDICAL-SURGICAL INC.MMK2022-07-28
10073088161854BEMISBemis de México, S.A. de C.V.MMK2022-04-07
10888277171022MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MMK2022-02-18
10888277171107MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MMK2022-02-18
10888277171145MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MMK2022-02-18