FDA.reportPublic FDA data

InStream

Primary DI
10724995184718
Brand
InStream
Company
US Endoscopy
Model
00711098
Catalog number
00711098
Device description
The single use InStream polyp trap is used for suction retrieval of endoscopically removed polyps.
Published
2020-03-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDQBOTTLE, COLLECTION, VACUUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995184718PackageGS150In Commercial Distribution
00816765010969PreviousGS10
00724995184711PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499518471810724995184718
00816765010969008167650109698167650109690816765010969
00724995184711007249951847117249951847110724995184711

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction system collection container, single-useA cylindrical or bottle-shaped sealable container intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
627879687
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995232177Fuji 700 4-piece Valve Kit1003401003402025-05-29
00724995182557Exacto00711094007110942021-03-31
00724995182564Exacto00711095007110952021-03-31
00724995182618Exacto00711115007111152021-03-31
00724995243746Exacto Mundo00711114007111142025-01-31
00724995180959VIA00717001007170012020-01-31
00724995181116VIA00717019007170192020-01-30
00724995181420VIA00717051007170512020-01-30
00724995181451VIA00717054007170542020-01-30
00724995181505VIA00717059007170592020-01-30
00724995181659VIA00717076007170762020-01-30
00724995182984VIA00717141007171412020-01-30
00724995183073VIA00717155007171552020-07-16
00724995183141VIA00717167007171672020-01-30
00724995183257VIA00717182007171822020-01-30
00724995190699VIA00717223007172232020-01-30
00724995190736VIA00717234007172342020-01-30
00724995193966VIA00717269007172692020-02-04
00724995194123VIA00717229007172292020-02-07
00724995194987VIA00717310007173102020-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850079671102NavägeRhinosystems, Inc.KDQ2026-06-10
14026704937247PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
14026704937254PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
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14026704937353PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
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40888277143020MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
40888277143518MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
40884389968070MEDLINEMEDLINE INDUSTRIES, INC.KDQ2025-11-28
14026704912190PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-09-17
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14026704911919PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911926PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911933PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911940PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
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10192253002645Thora-SealCardinal Health 200, LLCKDQ2025-02-18
10192253002669Thora-SealCardinal Health 200, LLCKDQ2025-02-18
10192253002676ArgyleCardinal Health 200, LLCKDQ2025-02-18