FDA.reportPublic FDA data

SecureSafe Safety Insulin Syringe

Primary DI
00616784890128
Brand
SecureSafe Safety Insulin Syringe
Company
Dynarex Corporation
Model
8901
Device description
U-100, 0.5 mL, 29G x 1/2"
Published
2017-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MEGSyringe, Antistick

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEGSyringe, AntistickGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191639000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
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
00616784890135PackageGS15In Commercial Distribution
00616784890128PrimaryGS10
00810180847087Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784890135006167848901356167848901350616784890135
00616784890128006167848901286167848901280616784890128
00810180847087008101808470878101808470870810180847087

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.

Regulatory Flags#

DUNS number
008124539
Device count
100
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00616784910413CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91042016-09-24
00616784910611CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91062016-09-24
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00616784914213CurPro Silk Sutures Natural Material, Braided Black, Nonabsorbable91422016-09-24
00616784914312CurPro Silk Sutures Natural Material, Braided Black, Nonabsorbable91432016-09-24
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