FDA.report

LithoVue Empower™

Primary DI
08714729977612
Brand
LithoVue Empower™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M0067919900
Device description
Retrieval Deployment Device
Published
2018-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FFYAdaptor, Bulbs, Miscellaneous, For Endoscope

Product Code Classifications

CodeDeviceSpecialtyClass
FFYAdaptor, Bulbs, Miscellaneous, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08714729977612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08714729977612087147299776128714729977612

GMDN Terms

TermDefinition
Surgical instrument handle gripA sterile device designed specifically to be attached to the handle (or holding portion) of a surgical instrument to provide grip for improved manipulation of the handle during surgical procedures. It is typically a synthetic polymer device designed for attachment to a handle and is not intended to provide a physical sterile barrier between the handle and the hand of a healthcare professional (i.e., not a handle cover). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
021717889
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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08714729195573RotaWire™ and wireClip™ TorquerH802232390010H8022323900102014-09-24
08714729195566RotaWire™ and wireClip™ TorquerH802228240020H8022282400202014-09-24
08714729837527Stingray™H749M3004A02016-09-24
08714729877523EP XT™M0042007720M00420077202016-09-24
08714729877714Dynamic XT™M0042011120M00420111202016-09-24
08714729879947EP XT™M0046EPXT00390M0046EPXT003902016-09-24
08714729181088Percuflex™ BiliaryM005337602015-09-24
08714729181095Percuflex™ BiliaryM005337702015-09-24
08714729181101Percuflex™ BiliaryM005337802015-09-24
08714729181118Percuflex™ BiliaryM005337902015-09-24
08714729181125Percuflex™ BiliaryM005338002015-09-24
08714729181132Percuflex™ BiliaryM005338102015-09-24
08714729181149Percuflex™ BiliaryM005338202015-09-24
08714729181156Percuflex™ BiliaryM005338302015-09-24
08714729181163Percuflex™ BiliaryM005338502015-09-24
08714729181217Percuflex™ BiliaryM005336102015-09-24
08714729181224Percuflex™ BiliaryM005336202015-09-24
08714729181231Percuflex™ BiliaryM005336302015-09-24
08714729181248Percuflex™ BiliaryM005336402015-09-24
08714729181255Percuflex™ BiliaryM005336502015-09-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
14547410564119FUJIFILMFUJIFILM CORPORATIONFFY2025-10-24
04897106957798Air/Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-08-04
14897106957801Air/Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-08-04
14897106957818Biopsy Port Cleaning AdapterGA Health Company LimitedFFY2025-08-04
14897106957825Air/Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-08-04
14897106957078Air Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-07-31
10850025860854CO2 Source Tubing Adapter Olympus UCRMicro-tech UsaFFY2025-05-12
10850025860861CO2 Source Tubing Adapter Fuji GW100Micro-tech UsaFFY2025-05-12
16009900408313PeditrolWISMED PL SP Z O OFFY2025-03-17
06009900408330Smart BulbWISMED PL SP Z O OFFY2025-03-17
06009900408439Mini PillowWISMED PL SP Z O OFFY2025-03-17
04547410516258FUJIFILMFUJIFILM CORPORATIONFFY2024-12-30
04547410522143FUJIFILMFUJIFILM CORPORATIONFFY2024-12-30
04049197151641RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFFY2024-10-16
04049197522496RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFFY2024-10-16
10810929044507AIR/WATER CLEANING VALVESRuhof CorporationFFY2024-10-15
00690521011526NON-STERILE Biopsy Valve Covers Batrik Medical Manufacturing IncFFY2024-10-08
00690521011533NON-STERILE Biopsy Valve Covers Batrik Medical Manufacturing IncFFY2024-10-08
00690521020672NON-STERILE Biopsy Valve Covers Batrik Medical Manufacturing IncFFY2024-10-08
00690521020689NON-STERILE Biopsy Valve Covers Batrik Medical Manufacturing IncFFY2024-10-08
04049197461054RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFFY2024-09-20
04049197461061RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFFY2024-09-20
04049197522465RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFFY2024-09-20
04049197522472RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFFY2024-09-20
04049197522489RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFFY2024-09-20
04055207019443E-LINERichard Wolf GmbHFFY2024-08-07
00840306830082Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FFY2024-08-06
00821925038646USA ELITEGyrus Acmi, Inc.FFY2024-07-24
00821925038653USA EliteGyrus Acmi, Inc.FFY2024-07-24
04055207018545E-LINERichard Wolf GmbHFFY2024-05-21