Veress Needle

Primary DI
24714127862006
Brand
Veress Needle
Company
UNIMAX MEDICAL SYSTEMS INC.
Model
FVN112000
Published
2017-01-09
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
FHOPneumoperitoneum Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHOPneumoperitoneum NeedleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111441000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111441000UNIMAX VERESS NEEDLEUnimax Medical Systems, Inc.2011-08-19HIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14714127862009PackageGS110In Commercial Distribution
24714127862006PackageGS1100In Commercial Distribution
04714127862002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471412786200914714127862009
2471412786200624714127862006
04714127862002047141278620024714127862002

GMDN Terms#

Term, Definition table
TermDefinition
Spring-loaded pneumoperitoneum needle, single-useA slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. It is equipped with a spring-loaded, round-tipped obturator that extends from the tube when the device does not encounter resistance (i.e., when the cavity has been reached) to prevent damage from the sharp point. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658122465
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
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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Primary DI, Brand, Model table
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15055515601572FemcareFN-100-1072025-10-14
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15055515601619FemcareFN-100-2102025-10-14
15055515601626FemcareFN-100-2112025-10-14
15055515602401FemcareFN-100-106-CA2025-10-14
15055515602418FemcareFN-100-210-CA2025-10-14
04714127861500UnimaxFEPC340802025-02-06
14714127861507UnimaxFEPC340802025-02-06
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14714127866700UnimaxFPL1330592021-08-10
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04714127860732CONMED12222019-12-17
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