FDA.reportPublic FDA data

AHTO

Primary DI
07613327052138
Brand
AHTO
Company
STRYKER CORPORATION
Model
0250070601
Catalog number
0250070601
Device description
Irrigation Pump
Published
2016-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCXAPPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
HETLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
KQTEVACUATOR, GASTRO-UROLOGY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2
KQTEvacuator, Gastro-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042454000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042454000STRYKER CASSETTE PUMPStryker Endoscopy2004-12-09GCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327052138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327052138076133270521387613327052138

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic irrigation/aspiration pumpA mains electricity (AC-powered) device intended to generate positive and/or negative pressures, to irrigate and/or aspirate a body cavity or lumen with sterile fluid (e.g., saline water) through an endoscope typically to facilitate observation of a site with an endoscope (e.g., during arthroscopy), and/or to keep clear the working channel of an endoscope or lumen of a catheter.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)624-4422xx@xx.xx

Regulatory Flags#

DUNS number
187502109
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327652703N/A72000152707200-015-2702026-04-15
07613327652710PROstep72000150437200-015-0432026-04-13
07613327652727N/A72010157107201-015-7102026-04-13
07613327652734N/A72000153707200-015-3702026-04-13
07613154599127NA59200002045920-000-2042018-09-24
07613327413281Connected OR Hub02402001000240-200-1002023-07-26
07613327051674AIM SafeLight02330503000233-050-3002016-09-23
07613327056167SDC3024006010102400601012016-09-23
07613327056174SDC3024006010202400601022016-09-23
07613327382389168816880201221688-020-1222019-01-17
07613327405910Precision IE 4K0502-444-0700502-444-0702019-01-21
07613327405927Precision IE 4K0502-445-0300502-445-0302019-01-21
07613327405934Precision IE 4K0502-444-0100502-444-0102019-01-21
07613327405941Precision IE 4K0502-445-0700502-445-0702019-01-21
07613327405958Precision IE 4K0502-444-0300502-444-0302019-01-21
07613327405965Precision IE 4K0502-445-0100502-445-0102019-01-21
07613327405972Precision IE 4K0502-444-0450502-444-0452019-01-21
07613327405989Precision IE 4K0502-444-1300502-444-1302019-01-21
07613327416299Precision IE 4K0502-194-0100502-194-0102019-01-21
07613327416305Precision IE 4K0502-194-0300502-194-0302019-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08682952418144DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-08
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10192253003062Aqua-SealCardinal Health 200, LLCGCX2025-02-18
10192253003079Sentinel SealCardinal Health 200, LLCGCX2025-02-18
10192253003086Sentinel SealCardinal Health 200, LLCGCX2025-02-18
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