FDA.reportPublic FDA data

Inorganic haemostatic agent, sterile

Definition
A sterile, non-bioabsorbable device made of mineral and/or synthetic polymer components (e.g., smectite, potassium ferrate/hydrophilic polymer) intended for application to a bleeding external epithelial wound [i.e., skin wound or gastrointestinal (GI) mucosa wound] to facilitate local haemostasis through formation of a sealant and/or clot acceleration; it may also be intended to absorb bodily fluids. It is available in various forms (e.g., powder, gel, impregnated gauze) intended to be applied directly or endoscopically to the wound temporarily; it does not contain an antimicrobial agent. Disposable devices to assist application may be included. This is a single-use device.
GUDID devices
73
Last updated
2022-02-07 10:24:04

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00834061000026WoundSeal®BIOLIFE, L.L.C.NCW0012022-01-28
00834061000040WoundSeal®BIOLIFE, L.L.C.CSU0042022-01-28
00834061000057WoundSeal®BIOLIFE, L.L.C.NPS0012022-01-28
00834061000064StatSeal®BIOLIFE, L.L.C.LP0062022-01-28
00834061000071StatSeal®BIOLIFE, L.L.C.LP0072022-01-28
00834061000101WoundSeal®BIOLIFE, L.L.C.QSO0102022-01-28
00834061000132StatSeal®BIOLIFE, L.L.C.DT0132022-01-28
00834061000149StatSeal®BIOLIFE, L.L.C.DS0142022-01-28
00834061000156StatSeal®BIOLIFE, L.L.C.DM0152022-01-28
00834061000163StatSeal®BIOLIFE, L.L.C.DL0162022-01-28
00834061000170StatSeal®BIOLIFE, L.L.C.DX0172022-01-28
00834061000187StatSeal®BIOLIFE, L.L.C.DA0182022-01-28
00834061000194StatSeal®BIOLIFE, L.L.C.DAP0192022-01-28
00834061000200StatSeal®BIOLIFE, L.L.C.DAR0202022-01-28
00834061000378WoundSeal®BIOLIFE, L.L.C.QSO020C2022-01-28
00834061000392WoundSeal®BIOLIFE, L.L.C.QSO010GC2022-01-28
00834061000446WoundSeal®BIOLIFE, L.L.C.QSO010ZC2022-01-28
00834061000453WoundSeal®BIOLIFE, L.L.C.WSO310GC2022-01-28
00834061000477WoundSeal®BIOLIFE, L.L.C.WSO310ZC2022-01-28
00834061000491WoundSeal®BIOLIFE, L.L.C.WSO310C2022-01-28
00834061003102WoundSeal®BIOLIFE, L.L.C.WSO3102022-01-28
00834061003195WoundSeal®BIOLIFE, L.L.C.WSO001GC2022-01-28
00834061003201WoundSeal®BIOLIFE, L.L.C.WSO001Z2022-01-28
00834061006318WoundSeal®BIOLIFE, L.L.C.WSO0012022-01-28
30841495140502QuikClotZ-MEDICA, LLC40502021-08-18
50841495105109QuikClotZ-MEDICA, LLC05102021-08-18
50841495120102QuikClotZ-MEDICA, LLC20102021-08-18
00841495105340QuikClotZ-MEDICA, LLC05342021-02-12
00841495105401QuikClotZ-MEDICA, LLC05402021-02-12
00841495105418QuikClotZ-MEDICA, LLC05412021-02-12
00841495105470QuikClotZ-MEDICA, LLC05472021-02-12
00841495105487QuikClotZ-MEDICA, LLC05482021-02-12
00841495102004QuikClotZ-MEDICA, LLC02002021-02-10
00841495104992QuikClotZ-MEDICA, LLC04992021-02-10
00841495105265QuikClotZ-MEDICA, LLC05262021-02-10
00841495105395QuikClotZ-MEDICA, LLC05392021-02-10
00841495105494QuikClotZ-MEDICA, LLC05492021-02-10
00841495105838QuikClotZ-MEDICA, LLC05832021-02-10
00841495106118QuikClotZ-MEDICA, LLC06112021-02-10
00841495106125QuikClotZ-MEDICA, LLC06122021-02-10
00841495106132QuikClotZ-MEDICA, LLC06132021-02-10
30841495106362QuikClotZ-MEDICA, LLC06362021-02-10
00841495106217QuikClotZ-MEDICA, LLC06212021-02-09
00841495106224QuikClotZ-MEDICA, LLC06222021-02-09
50841495105383QuikClotZ-MEDICA, LLC05382021-02-09
50841495105727QuikClotZ-MEDICA, LLC05722021-02-09
00841495102615QuikClotZ-MEDICA, LLC02612021-02-08
00841495101830QuikClotZ-MEDICA, LLC01832017-09-20
00841495101885QuikClotZ-MEDICA, LLC01882017-09-27
00841495102103QuikClotZ-MEDICA, LLC02102017-09-27
00841495103452QuikClotZ-MEDICA, LLC03452017-09-27
00841495103506QuikClotZ-MEDICA, LLC03502017-09-27
00841495103742QuikClotZ-MEDICA, LLC03742017-09-27
00841495104589QuikClotZ-MEDICA, LLC04582017-09-27
00841495104602QuikClotZ-MEDICA, LLC04602017-09-27
00841495104619QuikClotZ-MEDICA, LLC04612017-09-27
00841495104671QuikClotZ-MEDICA, LLC467Z2017-09-27
00841495104732QuikClotZ-MEDICA, LLC04732017-09-27
00841495104756QuikClotZ-MEDICA, LLC04752017-09-27
00841495104879QuikClotZ-MEDICA, LLC04872017-09-27
50841495102894QuikClotZ-MEDICA, LLC02892018-06-01
50841495104591QuikClotZ-MEDICA, LLC04592017-09-27
00841495140006QuikClotZ-MEDICA, LLC40002017-09-20
00841495140204QuikClotZ-MEDICA, LLC40202017-09-20
00827002210493HemosprayCOOK INCORPORATEDG210492018-05-25
00827002565722HemosprayCOOK INCORPORATEDG565722018-05-25
00841495140105QuikClotZ-MEDICA, LLC40102017-09-20
00841495140303QuikClotZ-MEDICA, LLC40302017-09-20
50841495103013QuikClotZ-MEDICA, LLC03012018-06-01
50841495103020QuikClotZ-MEDICA, LLC03022018-06-01
50841495103037QuikClotZ-MEDICA, LLC03032018-06-01
50841495106328QuikClotZ-MEDICA, LLC06322018-06-01
50841495106335QuikClotZ-MEDICA, LLC06332018-06-01