FDA.reportPublic FDA data

PMI

Primary DI
00812608021048
Brand
PMI
Company
PROGRESSIVE MEDICAL, INC.
Model
PMIIN12
Catalog number
PMIIN12
Device description
PMI Pneumoperitoneum Insufflation Needle 12cm
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10812608021045PackageGS110Not in Commercial Distribution
00812608021048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081260802104510812608021045
00812608021048008126080210488126080210480812608021048

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.

Contacts#

Phone, Email table
PhoneEmail
314-961-5786CS@PROGRSSIVEMEDINC.COM

Regulatory Flags#

DUNS number
192135242
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812608022328PMIPMICC512S2024-11-12
00812608022342PMIPMICCXLKT2024-11-12
00812608022304PMIPMICC5122024-11-12
00812608022335PMIPMICC512S2024-11-12
00812608022359PMIPMICCXLKT2024-11-12
00812608021444PMIK411CK411C2016-09-19
00812608020980PMIPMIORCAP20PMIORCAP202016-10-05
00812608020997PMIPMIXLPINPMIXLPIN2016-09-23
00812608021000PMIPMIXL11PMIXL112016-09-23
00812608021017PMIPMIORCBPMIORCB2016-09-23
00812608021024PMIPMILAP13PMILAP132016-09-23
00812608021031PMIPMIPIN152016-09-23
00812608021062PMIPMIORCA2016-09-23
00812608021529PMIPMIORCAP20PMIORCAP202017-08-01
00812608021543PMIPMIXLPINPMIXLPIN2017-08-01
00812608021734PMIPMICATH20PMICATH202018-01-22
00812608020232PMIPMISG10PMISG102016-09-23
00812608020256PMIPMISG12B2PMISG12B22016-09-23
00812608020270PMIPMISG12B4PMISG12B42016-09-23
00812608020119PMIPMI-500PMI-5002016-09-23

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
10884521080805SurgineedleCovidien LPFHO2016-09-24
20653405046032CORE DYNAMICSConmed CorporationFHO2016-09-24
20653405046049CORE DYNAMICSConmed CorporationFHO2016-09-24