FDA.reportPublic FDA data

Amniocentesis Needle

Primary DI
07350025912288
Brand
Amniocentesis Needle
Company
Vitrolife Sweden AB
Model
14801
Published
2016-09-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HIOSampler, Amniotic Fluid (Amniocentesis Tray)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIOSampler, Amniotic Fluid (Amniocentesis Tray)Obstetrics/Gynecology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K862365000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K862365000NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURESwemed Laboratories, Inc.1986-07-07HIO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17350025912285PackageGS110Not in Commercial Distribution
07350025912288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1735002591228517350025912285
07350025912288073500259122887350025912288

GMDN Terms#

Term, Definition table
TermDefinition
Amniocentesis kit, non-medicatedA 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, and dressings. 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.

Regulatory Flags#

DUNS number
631805488
Device count
1
Lot or batch
true
Expiration date on label
true

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