FDA.reportPublic FDA data

FLUID MANAGEMENT PACK

Primary DI
M648C0501000
Brand
FLUID MANAGEMENT PACK
Company
OBP CORPORATION
Model
C050100
Catalog number
C050100
Published
2016-09-21
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
NWWHysteroscope Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWWHysteroscope AccessoriesObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M648C0501001PackageHIBCC5In Commercial Distribution
M648C0501002PackageHIBCC8In Commercial Distribution
M648C0501000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, medicated, single-useA collection of various sterile urological surgical instruments, dressings, pharmaceuticals, and the necessary materials intended to be used to perform a urological surgical procedure; is not dedicated to a specific type of urological surgical procedure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity45 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius35 Degrees Celsius

Regulatory Flags#

DUNS number
011560431
Device count
1
Premarket exempt
true
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
M648C1002500ONETRAC LXC100250C1002502025-07-01
M648C1002501ONETRAC LXC100250C1002502025-07-01
M648C0601000ANOSPEC C060100 C060100 2016-09-21
M648C0601100ANOSPEC C060110 C060110 2016-09-21
M648C0601200ANOSPEC C060120 C060120 2016-09-21
M648C0601002ANOSPEC C060100 C060100 2016-09-21
M648C0601102ANOSPEC C060110 C060110 2016-09-21
M648C0601202ANOSPEC C060120 C060120 2016-09-21
M648C1102100ONETRAC LXSC110210C1102102022-04-15
M648C1102200ONETRAC LXSC110220C1102202022-04-15
M648C1102101ONETRAC LXSC110210C1102102022-04-15
M648C1102201ONETRAC LXSC110220C1102202022-04-15
M648C1002800ONETRAC LXC1002802021-06-02
M648C1002900ONETRAC LXC1002902021-06-02
M648C1002801ONETRAC LXC1002802021-06-02
M648C1002901ONETRAC LXC1002902021-06-02
M648C1102000ONETRAC LXSC110200C1102002021-04-12
M648C1102001ONETRAC LXSC110200C1102002021-04-12
M648C1002020ELBOW CONNECTORC1002022020-10-22
M648C1002021ELBOW CONNECTORC1002022020-10-22

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
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