Surgineedle

Primary DI
10884521080805
Brand
Surgineedle
Company
Covidien LP
Model
172015
Device description
Insufflation Needle
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K863330000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K863330000DISPOSABLE PNEUMOPERITONEUM NEEDLEUnited States Surgical, A Division of Tyco Healthc1986-10-02FHO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521080802PackageGS112In Commercial Distribution
10884521080805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452108080220884521080802
1088452108080510884521080805

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
Length120Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit130 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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10884521102422Steel88862345-532015-08-31
10884521103863TaperGuard18780S2016-09-24
10884521211933Shiley5-182372017-05-10
10884521543799SigniaSIGPSHELL2017-08-08
10884521713208EdgeE1455B2016-11-18
10884521713277EdgeE1475X2016-11-18
20884521103631Mallinckrodt5-182372015-08-28
20884521105574Mallinckrodt5-185412015-08-28
40884521105578Shiley5-185412018-05-16
10884521543881SigniaSIGMRET2017-07-24
10884521543874SigniaSIGRIG2017-07-31
10884521620254Shiley862342016-09-24
10884521543812SigniaSIGADAPTXL2017-08-08
10884521101098NellcorMAXPACAI2016-09-24
10884521543782SigniaSIGPHANDLE2017-08-08
10884521543867SigniaSIGSBCHGR2017-08-01
10884521128927SonicisionSCST2016-09-24
10884521543829SigniaSIGADAPTSHORT2017-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06937845500607GTKGuangzhou T.K Medical Instrument Co.,Ltd.FHO2024-05-23
06937845500614GTKGuangzhou T.K Medical Instrument Co.,Ltd.FHO2024-05-23
00850059707005AccuMedxAccumedx, LLCFHO2024-01-23
00850059707012AccuMedxAccumedx, LLCFHO2024-01-23
00810143450545MD EndoGuidance Laparoscopic InsufflatorMedical Disposables CorpFHO2023-07-31
00810143450750MD EndoGuidance Laparoscopic InsufflatorMedical Disposables CorpFHO2023-07-31
00858690006990INSUFFLATION NEEDLE,15CMRANFAC CORP.FHO2018-03-02
20858690006994INSUFFLATION NEEDLE,15CMRANFAC CORP.FHO2018-03-02
04714127862026Veress NeedleUNIMAX MEDICAL SYSTEMS INC.FHO2017-06-19
00821925002616THL Gyrus ACMI, LLCFHO2017-05-11
00858690006204INSUFFLATION NEEDLE,12CMRANFAC CORP.FHO2017-05-08
20858690006208INSUFFLATION NEEDLE,12CMRANFAC CORP.FHO2017-05-08
04714127862002Veress NeedleUNIMAX MEDICAL SYSTEMS INC.FHO2017-01-09
24714127862006Veress NeedleUNIMAX MEDICAL SYSTEMS INC.FHO2017-01-09
06955797740018Unimicro Unimicro Medical Systems (ShenZhen) Co., Ltd.FHO2016-12-22
06955797740025Unimicro Unimicro Medical Systems (ShenZhen) Co., Ltd.FHO2016-12-22
16955797740015Unimicro Unimicro Medical Systems (ShenZhen) Co., Ltd.FHO2016-12-22
16955797740022Unimicro Unimicro Medical Systems (ShenZhen) Co., Ltd.FHO2016-12-22
20884521080819SurgineedleCovidien LPFHO2016-10-20
10884521080812SurgineedleCovidien LPFHO2016-10-20
00821925001527USA SeriesGyrus ACMI, LLCFHO2016-10-14
00821925008915USA SeriesGyrus ACMI, LLCFHO2016-10-14
04055207039755NARichard Wolf GmbHFHO2016-09-27
04055207043097NARichard Wolf GmbHFHO2016-09-27
04055207043103NARichard Wolf GmbHFHO2016-09-27
04055207057988NARichard Wolf GmbHFHO2016-09-27
04055207057995NARichard Wolf GmbHFHO2016-09-27
20653405046032CORE DYNAMICSConmed CorporationFHO2016-09-24
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