FDA.reportPublic FDA data

TubeClear

Primary DI
00850458007102
Brand
TubeClear
Company
ACTUATED MEDICAL, INC.
Model
G-1010
Device description
Clearing Stem
Published
2017-10-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FPDTube, Feeding
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPDTube, FeedingGastroenterology, Urology2
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131052000
K172556000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131052000TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)Actuated Medical, Inc.2013-08-16KNT
K172556000TubeClear SystemActuated Medical, Inc.2018-06-29KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850458007109PackageGS15
20850458007106PackageGS110
00850458007102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085045800710910850458007109
2085045800710620850458007106
00850458007102008504580071028504580071020850458007102

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic manual linear staplerA sterile, hand-held, manual surgical instrument intended to be used during abdominal, gynaecological, paediatric, and thoracic endoscopic (i.e., endotherapy) surgery for the application of surgical staples to approximate internal soft tissues (e.g., two ends of bowel) or for fixation of a surgical mesh to tissue during a laparoscopic procedure; it has no cutting function and may be used during open surgery. The device operates by a manual mechanism (e.g., trigger mechanism) whereby it applies single or multiple linear rows of surgical staples to a portion of tissue. The staples may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device.

Regulatory Flags#

DUNS number
791379030
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850458007089TubeClearG-10082017-10-02
00850458007096TubeClearG-10092017-10-02
00850458007119TubeClearG-10112017-10-02
00850458007126TubeClearG-10122016-10-27
00850458007140TubeClearG-10142016-10-27
00850458007423TubeClear NE-10422016-10-27
00850458007430TubeClearNE-10432016-10-27
00850458007454TubeClearNE-10452017-10-02
00850458007485TubeClearNE-10482016-10-27
00850458007508TubeClearNE-10502016-10-27
00850458007553TubeClearNE-10552016-10-27
00850458007607TubeClearTC-06082017-03-02
00850458007614TubeClearTC-08122017-03-02
00850458007621TubeClearTC-10182017-10-02
00850458007010TubeClearControl Box Model 101101-US2016-09-08
00850458007362TubeClearNE-10362016-10-27
00850458007195GripTract-GI Endoscopic Tissue ManipulatorGT-GS1002025-12-23
00850458007041GripTract-GI Endoscopic Tissue ManipulatorGT-1012025-01-16
00850458007003TubeClearGJ-1422GJ-14222021-01-01
00850458007157GripTract-GI Endoscopic Tissue ManipulatorGT-CM1302025-01-16

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Primary DI, Brand, Company table
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