FDA.reportPublic FDA data

SecureSafe Safety Insulin Syringe

Primary DI
00616784890524
Brand
SecureSafe Safety Insulin Syringe
Company
Dynarex Corporation
Model
8905
Published
2017-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston
MEGSyringe, Antistick

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
MEGSyringe, AntistickGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150758000
K191639000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150758000
K191639000TK Insulin Syringe with/without Saftey Retractable DeviceAnhui Tiankang Medical Technology Co., Ltd.2020-09-11MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784890524PrimaryGS10
00616784890517Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784890524006167848905246167848905240616784890524
00616784890517006167848905176167848905170616784890517

GMDN Terms#

Term, Definition table
TermDefinition
Insulin syringe/needle, safetyA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; it includes an attached needle with a safety mechanism, such as cylinder/flap shielding or retraction into the barrel or sleeve after use, providing protection against needle sticks and rendering the device unusable. The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties (internally precoated with compatible substances) allowing smooth plunger movement. It can be used by healthcare personnel or patients.. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
100

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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