FDA.reportPublic FDA data

Insertion Package

Primary DI
00878953000558
Brand
Insertion Package
Company
BOSTON SCIENTIFIC CORPORATION
Model
72100005
Catalog number
72100005
Device description
Tubing Passer
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JCWProsthesis, Penis, Inflatable
QGAPenile implant surgical accessories
QGDImplanted mechanical/hydraulic urinary continence device surgical accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCWProsthesis, Penis, InflatableGastroenterology, Urology3
QGAPenile Implant Surgical AccessoriesGastroenterology, Urology1
QGDImplanted Mechanical/Hydraulic Urinary Continence Device Surgical AccessoriesGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00878953000534Direct MarkingGS10
00878953000558PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00878953000534008789530005348789530005340878953000534
00878953000558008789530005588789530005580878953000558

GMDN Terms#

Term, Definition table
TermDefinition
Wire/ligature passer, reusableA hand-held, manual surgical instrument designed for passing a length of a flexible material/device, typically a wire, ligature, or orthopaedic graft gauge, through a surgical site by creating a pathway through tissue and facilitating the introduction and handling of the material/device. It may also be referred to as a carrier and is typically in the form of a shaft with a distal clasp, grasping arm, or cannulated hook to hold the material being passed through the tissue. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
021717889
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506063191OPAL HDx™M004OPAL14010M004OPAL140102026-10-28
08714729840442SYNERGY™H7493926108220H74939261082202016-01-14
08714729840459SYNERGY™H7493926108250H74939261082502016-01-14
08714729840466SYNERGY™H7493926108270H74939261082702016-01-14
08714729840473SYNERGY™H7493926108300H74939261083002016-01-14
08714729840480SYNERGY™H7493926108350H74939261083502016-01-14
08714729840497SYNERGY™H7493926108400H74939261084002016-01-14
08714729840503SYNERGY™H7493926112220H74939261122202016-01-14
08714729840510SYNERGY™H7493926112250H74939261122502016-01-14
08714729840527SYNERGY™H7493926112270H74939261122702016-01-14
08714729840534SYNERGY™H7493926112300H74939261123002016-01-14
08714729840541SYNERGY™H7493926112350H74939261123502016-01-14
08714729840558SYNERGY™H7493926112400H74939261124002016-01-14
08714729840565SYNERGY™H7493926116220H74939261162202016-01-14
08714729840572SYNERGY™H7493926116250H74939261162502016-01-14
08714729840589SYNERGY™H7493926116270H74939261162702016-01-14
08714729840596SYNERGY™H7493926116300H74939261163002016-01-14
08714729840602SYNERGY™H7493926116350H74939261163502016-01-14
08714729840619SYNERGY™H7493926116400H74939261164002016-01-14
08714729840626SYNERGY™H7493926120220H74939261202202016-01-14

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