Oak Ridge Products

GUDID 10865273000006

2.2 Quart Sharp Container - Rotary lid - RED

OAKRIDGE PRODUCTS, LLC

Sharps container

Primary Device ID	10865273000006
NIH Device Record Key	398baf37-4ba5-4a88-9f31-d8b3a993fdfc
Commercial Distribution Status	In Commercial Distribution
Brand Name	Oak Ridge Products
Version Model Number	0322-150R
Company DUNS	111322165
Company Name	OAKRIDGE PRODUCTS, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Device Dimensions

Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart
Total Volume	2.2 Quart

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865273000009 [Primary]
GS1	10865273000006 [Package] Contains: 00865273000009 Package: Case [60 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K161180

FDA Product Code

MMK	Container, Sharps

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-03-29
Device Publish Date	2016-09-22

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10865273000051	5.4 quart Sharps Container Counterbalanced B Lid- Red
10865273000044	5 quart Sharps Container Horizontal Drop - Red
10865273000037	5 quart Sharps Container M lid Counterbalanced - Red
10865273000020	2 Gallon Sharps Container Slide lid - RED
10865273000013	Phlebotomy Sharps Container 1 quart - RED
10865273000006	2.2 Quart Sharp Container - Rotary lid - RED
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10852482006554	Medium Multi-Purpose Sharps Container Rotary lid - RED
10852482006530	Phlebotomy Sharps Container 1 quart - Yellow
10852482006523	Medium Multi-Purpose Sharps Container Slide lid - RED
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