FDA.reportPublic FDA data

Endure

Primary DI
00840118604277
Brand
Endure
Company
ENDURE INDUSTRIES
Model
NS211A3-0820
Catalog number
NS211A3
Device description
"Safety needle 21G, 1"""
Published
2021-04-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142765000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142765000TM SAFETY NEEDLEThinkmed Medical Technology Co., Ltd.2015-08-11FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840118604284PackageGS1100In Commercial Distribution
00840118604291PackageGS120In Commercial Distribution
00840118604277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840118604284008401186042848401186042840840118604284
00840118604291008401186042918401186042910840118604291
00840118604277008401186042778401186042770840118604277

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1Inch
Needle Gauge21Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius49 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
6072994971Support@endureind.com

Regulatory Flags#

DUNS number
066087031
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840118608046ENDURE INDUSTRIESNROMA11NROMA112024-04-01
00840118608060ENDURE INDUSTRIESNROMP11NROMP112024-04-10
00840118611619ENDURE INDUSTRIESNROMPE11NROMPE112024-04-10
00840118611633ENDURE INDUSTRIESNROMAE11NROMAE112024-04-01
00840118612791ENDURE INDUSTRIESA2001A20012023-10-15
00840118613958ENDURE INDUSTRIESNDAM211NDAM2112026-05-01
08697645018129ENDURE INDUSTRIESAMT4MAMT4M2026-04-17
08697645018136ENDURE INDUSTRIESAMT5M2026-04-17
08697645018143ENDURE INDUSTRIESAMT6MAMT6M2026-04-17
08697645018150ENDURE INDUSTRIESBGE7MBGE7M2026-04-17
08697645018167ENDURE INDUSTRIESBGE9MBGE9M2026-04-17
08697645018174ENDURE INDUSTRIESBGA7MBGA7M2026-04-17
08697645018181ENDURE INDUSTRIESBGA9M BGA9M 2026-04-17
08697645018198ENDURE INDUSTRIESBB1MBB1M2026-04-17
00840118603676EndureSLL1A3-0520SLL1A32021-04-06
00840118603706EndureSLL2A3-0520SLL2A32020-08-31
00840118603737EndureSLL3A3-0520SLL3A32021-07-25
00840118603768EndureSLL5A3-0520SLL5A32020-08-31
00840118603799EndureSLL10A3-0520SLL10A32020-08-31
00840118603829EndureSLL20A3-0520SLL20A32020-08-31

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