FDA.reportPublic FDA data

AutoCap™ RX

Primary DI
00191506040215
Brand
AutoCap™ RX
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00545120
Catalog number
M00545120
Device description
Integrated Biopsy Cap and Guidewire Locking Device
Published
2024-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ODCEndoscope channel accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506040215PackageGS110In Commercial Distribution
00191506040208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506040215001915060402151915060402150191506040215
00191506040208001915060402081915060402080191506040208

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic guidewire holderA device intended to be used during diagnostic and/or therapeutic endoscopy of the gastrointestinal (GI) tract [e.g., endoscopic retrograde cholangiopancreatography (ERCP)] to hold a guidewire in place at a given insertion depth through the working channel of an endoscope. It is typically a small plastic device intended to be attached to the proximal end of the endoscope, with a feature to hold the guidewire in place (e.g., j-slot). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00802526613876LATITUDE® NXT646064602020-04-09
08714729893431ROTAPRO™ AdvancerH74939299A02018-07-11
08714729999560ROTAPRO™H749394671250H7493946712502020-07-01
08714729999577ROTAPRO™H749394671500H7493946715002020-07-01
08714729999584ROTAPRO™H749394671750H7493946717502020-07-01
08714729999591ROTAPRO™H749394672000H7493946720002020-07-01
08714729999607ROTAPRO™H749394672150H7493946721502020-07-01
08714729999614ROTAPRO™H749394672250H7493946722502020-07-01
08714729999621ROTAPRO™H749394672380H7493946723802020-07-01
08714729999638ROTAPRO™H749394672500H7493946725002020-07-01
00191506062620RIVOS™M00553900M005539002026-06-25
08714729050650Entry KitM001503500M0015035002016-01-29
08714729082026SteeroCath-Dx™M0042028BL02016-09-24
08714729085249Electrophysiology CableM00490002016-09-24
08714729114659Greenfield™M001503000M0015030002015-09-24
08714729114666Greenfield™M001503010M0015030102015-09-24
08714729124993Greenfield™M001505010M0015050102015-09-24
08714729270249Electrophysiology CableM004901AS02016-09-24
08714729270256Electrophysiology CableM004901BS02016-09-24
08714729334996Electrophysiology CableM004921B02016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850050934196EndoSound® Biopsy Port Adapter 5054Endosound, Inc.ODC2026-06-01
00850050934202EndoSound® Biopsy Port Adapter (5 pack) 5064Endosound, Inc.ODC2026-06-01
00724995246693DEFENDO Disposable Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246709DEFENDO Disposable Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246716DEFENDO Biopsy Valve IrrigatorMEDIVATORS INC.ODC2026-04-06
00724995246723DEFENDO Air/Water/Suction and Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246730DEFENDO Air/Water and Suction ValvesMEDIVATORS INC.ODC2026-04-06
00724995246747DEFENDO Valve and Connector KitMEDIVATORS INC.ODC2026-04-06
00724995246754Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246761Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246778Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246785Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246792DEFENDO Valve and Connector KitMEDIVATORS INC.ODC2026-04-06
00724995246808DEFENDO Air/Water/Suction and Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246815DEFENDO Air/Water and Suction ValvesMEDIVATORS INC.ODC2026-04-06
00724995246846DEFENDO SINGLE USE VALVE KITMEDIVATORS INC.ODC2026-04-06
04897106957880andorate® 2-piece Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedODC2026-03-13
04897106957897andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedODC2026-03-13
04897106957910andorate® 4-piece valve kitGA Health Company LimitedODC2026-03-12
00724995247300NAMEDIVATORS INC.ODC2026-03-02
04897106957835Champion 3-piece valve kitGA Health Company LimitedODC2026-01-21
04897106957842Champion 3-piece valve kitGA Health Company LimitedODC2026-01-21
04897106957859Champion 4-piece valve kitGA Health Company LimitedODC2026-01-21
04897106957866Air Water Channel Cleaning Adapter + Champion 3-piece Valve KitGA Health Company LimitedODC2026-01-21
04897106957903Champion 3-piece valve kitGA Health Company LimitedODC2026-01-21
04897106957927Air Water Channel Cleaning Adapter + Champion 3-piece Valve KitGA Health Company LimitedODC2026-01-21
04897106957934Air Water Channel Cleaning Adapter + Champion 4-piece Valve KitGA Health Company LimitedODC2026-01-21
04897106957576andorate® Champion 3-piece Valve KitGA Health Company LimitedODC2025-11-21
04897106957583andorate® Champion 4-piece valve kitGA Health Company LimitedODC2025-11-21
04897106957644Air Water Channel Cleaning Adapter + Champion 4-piece Valve KitGA Health Company LimitedODC2025-10-30