FDA.reportPublic FDA data

Iotec

Primary DI
10884521080799
Brand
Iotec
Company
Covidien LP
Model
1012A
Device description
Pneumoperitoneum Needle
Published
2016-09-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIFINSUFFLATOR, LAPAROSCOPIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIFInsufflator, LaparoscopicObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521080796PackageGS112Not in Commercial Distribution
10884521080799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452108079620884521080796
1088452108079910884521080799

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.

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
Primary DIBrandModelCatalogPublished
10884521038967ValleylabE250510FRNSB2025-03-27
10884524002880ValleylabE250510FRNSB2025-03-27
10884521039100ValleylabE3310NSB2016-09-24
10884521141117WarmTouch50308902019-02-06
10884521205024Shiley4CN65R2016-09-24
10884521205420Shiley5CN70R2016-09-24
10884521205437Shiley6CN75R2016-09-24
10884521205444Shiley7CN80R2016-09-24
10884521205451Shiley8CN85R2016-09-24
10884521205468Shiley9CN90R2016-09-24
10884521205475Shiley10CN10R2016-09-24
10884521205482Shiley4UN65R2016-09-24
10884521205499Shiley5UN70R2016-09-24
10884521205505Shiley6UN75R2016-09-24
10884521205512Shiley7UN80R2016-09-24
10884521205529Shiley8UN85R2016-09-24
10884521205536Shiley9UN90R2016-09-24
10884521205543Shiley10UN10R2016-09-24
10884521815360NellcorMAXFAST2021-08-09
10884521815469NellcorMAXFASTI2021-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973031299207InsufflatorGuangdong Optomedic Technologies, Inc.HIF2026-04-22
04046955813360AESCULAPAesculap AGHIF2025-12-02
B3543000011ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000012ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000013ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000014ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000015ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000019ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000010ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
04046955813353AESCULAPAesculap AGHIF2025-05-18
04953170467219HIGH FLOW INSUFFLATION UNITOLYMPUS MEDICAL SYSTEMS CORP.HIF2025-02-27
04055207007822NARichard Wolf GmbHHIF2024-08-19
04055207008393NARichard Wolf GmbHHIF2024-08-19
04055207058985NARichard Wolf GmbHHIF2024-08-19
05391536920937EVA15PALLIARE LIMITEDHIF2024-07-16
10845854045633AIRSEALConmed CorporationHIF2024-03-27
00886874120699NoneINTUITIVE SURGICAL, INC.HIF2024-03-25
B354OSLPCDG1Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG2Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG3Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG4Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG5Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG51Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG9Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG0Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
00850059707005AccuMedxAccumedx, LLCHIF2024-01-23
00850059707012AccuMedxAccumedx, LLCHIF2024-01-23
10845854045367CONMEDConmed CorporationHIF2023-12-04
09420012433978Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDHIF2023-07-06
10850082007186Filter AssemblyARMM INC.HIF2023-06-08