FDA.reportPublic FDA data

PNEUMOSTOP®

Primary DI
00850012846000
Brand
PNEUMOSTOP®
Company
LSI Solutions, Inc.
Model
110200
Catalog number
110200
Device description
PNEUMOSTOP® DEVICE
Published
2022-11-04
Public version status
New
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
NWWHysteroscope accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWWHysteroscope AccessoriesObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850012846007PackageGS16In Commercial Distribution
00850200006742PreviousGS10
00850012846000PrimaryGS10
40850012846008Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001284600710850012846007
00850200006742008502000067428502000067420850200006742
00850012846000008500128460008500128460000850012846000
4085001284600840850012846008

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic hysterectomy vaginal occluderA semi-soft device designed to be inserted into the vagina to maintain pneumoperitoneum during removal of the uterus during laparoscopic hysterectomy. It is in the form of a cylinder with ridges and is made of synthetic polymer materials. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(866)575-3493regulatorydpt@lsisolutions.com

Regulatory Flags#

DUNS number
603420183
Device count
3
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850012846703PicoDriver0234700234702026-04-28
00850012846246MD™ QUICK LOAD®0231600231602022-12-22
00850012846529RD® QUICK LOAD®0233870233872025-07-09
00850012846543RAM® COR-SUTURE® QUICK LOAD®0234070234072025-07-28
00850200006148RD® QUICK LOAD®0209790209792015-12-04
00850200006346COR-SUTURE® QUICK LOAD®0218610218612016-05-12
00850200006353COR-SUTURE® QUICK LOAD®0218620218622016-05-12
00850200006407RAM® COR-SUTURE® QUICK LOAD®0220900220902018-06-02
00850200006438RAM® COR-SUTURE® QUICK LOAD®0220470220472018-06-02
00850200006445RAM® COR-SUTURE® QUICK LOAD®0220390220392020-03-13
00850200006452RAM® COR-SUTURE® QUICK LOAD®0223350223352020-03-13
00850200006469RAM® COR-SUTURE® QUICK LOAD®0223200223202020-03-13
00850200006476RAM® COR-SUTURE® QUICK LOAD®0223250223252020-03-13
00850200006483RAM® COR-SUTURE® QUICK LOAD®0223400223402020-03-13
00850200006766RAM® COR-SUTURE® QUICK LOAD®0226680226682020-03-13
00850200006773RAM® COR-SUTURE® QUICK LOAD®0226710226712020-03-13
00850200006780RAM® COR-SUTURE® QUICK LOAD®0226740226742020-03-13
00850200006797RAM® COR-SUTURE® QUICK LOAD®0226800226802020-03-13
00850200006803RAM® COR-SUTURE® QUICK LOAD®0226830226832020-03-13
00850200006810RAM® COR-SUTURE® QUICK LOAD®0226860226862020-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974880994343Omni® Hysteroscopic GrasperSuzhou AcuVu medical technology Co., Ltd.NWW2026-04-17
00190776420208MillenniumAvalign Technologies, Inc.NWW2026-04-16
05708265017881LiNA OperaScope™ Lasso LiNA Medical AGNWW2026-04-03
05708265017904LiNA OperaScopeTM LassoLiNA Medical AGNWW2026-04-03
05708265017928LiNA OperaScope Angled LassoLiNA Medical AGNWW2026-04-03
05708265017942LiNA OperaScope Angled LassoLiNA Medical AGNWW2026-04-03
05708265017980LiNA OperaScope™ ScissorsLiNA Medical AGNWW2026-04-03
00190776416379MillenniumAvalign Technologies, Inc.NWW2026-02-16
00850033976359HERizon Disposable Endoscopic Scissors XLMinerva Surgical, Inc.NWW2026-02-13
10850033976356HERizon Disposable Endoscopic Scissors XLMinerva Surgical, Inc.NWW2026-02-13
00198506087943ELMED INCORPORATEDELMED INCORPORATEDNWW2026-01-16
00190776410872MillenniumAvalign Technologies, Inc.NWW2025-09-15
00190776410544MillenniumAvalign Technologies, Inc.NWW2025-09-11
06976860690412OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690429OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690436OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690443OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690450OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690467OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690474OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690481OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690498OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690504OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690511OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690528OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690535OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690542OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690559OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690566OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690573OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28