FDA.reportPublic FDA data

Pneumo-Matic

Primary DI
00888937003673
Brand
Pneumo-Matic
Company
Coopersurgical, Inc.
Model
900-210
Device description
14 Gauge Insufflation Needle
Published
2016-06-07
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

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
K970788000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970788000PNEUMO-MATIC INSUFFLATION NEEDLEApple Medical Corp.1997-03-27FHO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937003677PackageGS110In Commercial Distribution
00888937003673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893700367720888937003677
00888937003673008889370036738889370036730888937003673

GMDN Terms#

Term, Definition table
TermDefinition
Simple pneumoperitoneum needleA 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. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length150Millimeter

Regulatory Flags#

DUNS number
801895244
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888937033687ONETRACC1001502026-07-10
00888937033694ONETRACC1001652026-07-10
00888937033700ONETRACC1001702026-07-10
00888937033717ONETRACC1001802026-07-10
00888937033724ONETRACC1001902026-07-10
00888937033731ONETRAC LXC1002102026-07-10
00888937033748ONETRAC LXC1002202026-07-10
00888937033755ONETRAC LXC1002302026-07-10
00888937033762ONETRAC LXC1002402026-07-10
00888937033779ONETRAC LXC1002502026-07-10
00888937033786ONETRAC™ LXSC1002602026-07-10
00888937033793ONETRAC™ LXSC1002702026-07-10
00888937033809ONETRAC™ LXSC1002802026-07-10
00888937033816ONETRAC™ LXSC1002902026-07-10
00888937033823ONETRAC™ LXSC1102002026-07-10
00888937033830ONETRAC™ LXSC1102102026-07-10
00888937033847ONETRAC™ LXSC1102202026-07-10
00888937033854ONETRAC™ LXSC1103102026-07-10
00888937033861ONETRAC™ LXSC1103202026-07-10
00888937033663ONETRAC™C1001102026-07-09

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