Amniocentesis Tray, 20 G x 3 1/2 Inch Spinal Needle With Centimeter Depth Markings

Amniocentesis Tray, 20 G x 3 1/2 Inch Spinal Needle With Centimeter Depth Markings
N/A - 4545A

A collection of sterile devices designed to aspirate and contain a sample of amniotic fluid from the amniotic sac, via a transabdominal approach, for analysis. Components typically include a needle with stylet and syringe, specimen containers/medium, drapes, dressings, and pharmaceuticals. The device is typically used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities (e.g., Down syndrome, spina bifida), or anytime after 24-weeks gestation to assess foetal maturity. This is a single-use device.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: HIO

Device Name: Sampler, Amniotic Fluid (Amniocentesis Tray)

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: OB

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 884.1550

Third Party Flag: N

Medical Specialty: OB

Device Id: 50885403057128

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10885403057120

Package Quantity: 10

Package Discontinue Date: 12/20/2023 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Case

Device Id: 10885403057120

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A