FDA.report

Rospital Prpductos Medicos

Primary DI
10812460027445
Brand
Rospital Prpductos Medicos
Company
ATLAS MEDICAL PRODUCTS LLC
Model
SUDN025
Catalog number
SUDN025
Device description
HYPODERMIC, NEEDLES, STERILE, BLISTER, LUER LOCK - 25 G x 5/8" -EA.
Published
2020-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications

CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10812460027445PackageGS1100In Commercial Distribution
20812460027442PackageGS1100In Commercial Distribution
00812460027448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081246002744510812460027445
2081246002744220812460027442
00812460027448008124600274488124600274480812460027448

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
786-473-9436LEVALENZUELA17@GMAIL.COM

Regulatory Flags

DUNS number
013112308
Device count
1
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10812460020392ROSPITAL PRODUCTOS MEDICOSELSELS2024-08-23
00812460021484ROSPITAL PRODUCTOS MEDICOSELSPELSP2024-08-23
00812460024799ROSPITAL PRODUCTOS MEDICOSESPWHESPWH2024-08-23
10812460024765Rospital Producos MedicosSY05WN31516SY05WN315162024-04-16
10812460024772Rospital Productos MedicosSY05WN32516SY05WN325162024-04-16
10812460024789Rospital Productos MedicosSY05WN3012SY05WN30122024-04-16
10812460026240Rospital Productos MedicosSY1WN32516SY1WN325162024-04-16
10812460026271Rospital Productos MedicosSY1WN3012SY1WN30122024-04-16
10812460026295Rospital Productos MedicosSY1WN31516SY1WN315162024-04-16
10812460021344Rospital Productos MedicosAMPRG361002023-03-17
10812460025045Rospital Productos MedicosSBP22SBP222023-03-17
10812460020774Rospital Productos MedicosGS4021262022-10-21
10812460020828Rospital Productos MedicosCW500101CW5001012022-10-21
10812460021962Rospital Productos MedicosGS4021284021282022-10-21
10812460025083Rospital Productos MedicosGS402122GS4021222022-10-21
10812460026905Rospital Productos MedicosSY2021SY20212020-06-13
10812460026936Rospital Productos MedicosSY325SY3252020-06-13
10812460026943Rospital Productos MedicosSY321SY3212020-06-13
10812460026950Rospital Productos MedicosSY3215SY32152020-06-13
10812460026967Rospital Productos MedicosSY3225SY32252020-06-13

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