Assure® ID Safety Pen Needle

GUDID 56971227400371

The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. The products has several models. Diffe

Promisemed Hangzhou Meditech Co., Ltd.

Autoinjector needle
Primary Device ID56971227400371
NIH Device Record Key566003bd-1ea3-4b93-ac7d-87c2283e33f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAssure® ID Safety Pen Needle
Version Model NumberSPN-30-8
Company DUNS421335278
Company NamePromisemed Hangzhou Meditech Co., Ltd.
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS116971227400373 [Unit of Use]
GS136971227400377 [Primary]
GS156971227400371 [Package]
Contains: 36971227400377
Package: carton [12 Units]
In Commercial Distribution

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[56971227400371]

Radiation Sterilization


[56971227400371]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2018-01-12

On-Brand Devices [Assure® ID Safety Pen Needle]

56971227400395The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and singl
36971227400384The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and singl
56971227400371The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and singl

Trademark Results [Assure]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ASSURE
ASSURE
98452802 not registered Live/Pending
Aqua Horizon LLC
2024-03-16
ASSURE
ASSURE
98235302 not registered Live/Pending
Caris MPI, Inc.
2023-10-23
ASSURE
ASSURE
98144267 not registered Live/Pending
Superior Plastics Extrusion Co Inc
2023-08-22
ASSURE
ASSURE
97901492 not registered Live/Pending
Resilient Floor Covering Institute, Inc.
2023-04-21
ASSURE
ASSURE
97614385 not registered Live/Pending
PerkinElmer Health Sciences, Inc.
2022-09-30
ASSURE
ASSURE
97526467 not registered Live/Pending
Qualia Labs, Inc.
2022-07-29
ASSURE
ASSURE
97448887 not registered Live/Pending
PRESTIGE MARKETING, LTD.
2022-06-08
ASSURE
ASSURE
90315893 not registered Live/Pending
LSI Wallcovering, Inc.
2020-11-12
ASSURE
ASSURE
90238064 not registered Live/Pending
Azure Biotech, Inc.
2020-10-06
ASSURE
ASSURE
90030227 not registered Live/Pending
Zep IP Holding LLC
2020-07-01
ASSURE
ASSURE
88908804 not registered Live/Pending
Syed Doha, Inc.
2020-05-10
ASSURE
ASSURE
88837750 not registered Live/Pending
West Affum Holdings Corp.
2020-03-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.