FDA.reportPublic FDA data

Furlow

Primary DI
00191506022181
Brand
Furlow
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00635400020
Catalog number
M00635400020
Device description
Disposable Insertion Tool
Published
2022-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QGAPenile implant surgical accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QGAPenile Implant Surgical AccessoriesGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506022181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506022181001915060221811915060221810191506022181

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

Regulatory Flags#

DUNS number
021717889
Device count
1
Premarket exempt
true
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
00191506049232Orbera™M00505670M005056702026-06-04
08714729121190Ultraflex™ Esophageal NGM005142002015-09-24
08714729121206Ultraflex™ Esophageal NGM005142102015-09-24
08714729121213Ultraflex™ Esophageal NGM005142202015-09-24
08714729121220Ultraflex™ Esophageal NGM005142302015-09-24
08714729649113Ultraflex™ Esophageal NGM005137502015-09-24
08714729716075Ultraflex™ Esophageal NGM005138502015-09-24
08714729716082Ultraflex™ Esophageal NGM005138602015-09-24
08714729716099Ultraflex™ Esophageal NGM005138402015-09-24
08714729716105Ultraflex™ Esophageal NGM005142402015-09-24
08714729716112Ultraflex™ Esophageal NGM005142502015-09-24
08714729716129Ultraflex™ Esophageal NGM005137002015-09-24
08714729716136Ultraflex™ Esophageal NGM005137102015-09-24
08714729716143Ultraflex™ Esophageal NGM005137202015-09-24
08714729716150Ultraflex™ Esophageal NGM005137302015-09-24
08714729716167Ultraflex™ Esophageal NGM005137402015-09-24
08714729716174Ultraflex™ Esophageal NGM005138002015-09-24
08714729716181Ultraflex™ Esophageal NGM005138102015-09-24
08714729716198Ultraflex™ Esophageal NGM005138202015-09-24
08714729716204Ultraflex™ Esophageal NGM005138302015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956416789CARDINAL HEALTHCardinal Health 200, LLCQGA2026-04-21
10198956437012CARDINAL HEALTHCardinal Health 200, LLCQGA2026-04-09
10198956340510CARDINAL HEALTHCardinal Health 200, LLCQGA2026-03-23
50198956340518CARDINAL HEALTHCardinal Health 200, LLCQGA2026-03-23
10198956289710CARDINAL HEALTHCardinal Health 200, LLCQGA2026-03-19
50198956289718CARDINAL HEALTHCardinal Health 200, LLCQGA2026-03-19
10198956101609CARDINAL HEALTHCardinal Health 200, LLCQGA2026-01-26
50198956101607CARDINAL HEALTHCardinal Health 200, LLCQGA2026-01-26
10198956292017CARDINAL HEALTHCardinal Health 200, LLCQGA2026-01-22
50198956292015CARDINAL HEALTHCardinal Health 200, LLCQGA2026-01-22
10198956252929CARDINAL HEALTHCardinal Health 200, LLCQGA2025-12-10
50198956252927CARDINAL HEALTHCardinal Health 200, LLCQGA2025-12-10
10198956265189CARDINAL HEALTHCardinal Health 200, LLCQGA2025-11-17
50198956265187CARDINAL HEALTHCardinal Health 200, LLCQGA2025-11-17
10198956206328CARDINAL HEALTHCardinal Health 200, LLCQGA2025-10-20
10198956136281CARDINAL HEALTHCardinal Health 200, LLCQGA2025-08-22
50198956136289CARDINAL HEALTHCardinal Health 200, LLCQGA2025-08-22
10198956165373CARDINAL HEALTHCardinal Health 200, LLCQGA2025-08-11
10198956167193CARDINAL HEALTHCardinal Health 200, LLCQGA2025-08-11
50198956165371CARDINAL HEALTHCardinal Health 200, LLCQGA2025-08-11
50198956167191CARDINAL HEALTHCardinal Health 200, LLCQGA2025-08-11
10198956128682CARDINAL HEALTHCardinal Health 200, LLCQGA2025-07-29
50198956128680CARDINAL HEALTHCardinal Health 200, LLCQGA2025-07-29
00850033207811RIGICON DILATOM™Rigicon, Inc.QGA2024-06-26
00850033207828RIGICON DILATOM™Rigicon, Inc.QGA2024-06-26
00850033207842RIGICON DILATOM™Rigicon, Inc.QGA2024-06-26
00850033207873RIGICON DILATOM™ Rigicon, Inc.QGA2024-06-26
00850033207880RIGICON DILATOM™Rigicon, Inc.QGA2024-06-26
00878953005386SizerBOSTON SCIENTIFIC CORPORATIONQGA2017-03-31
00878953000176Furlow Insertion ToolBOSTON SCIENTIFIC CORPORATIONQGA2014-09-25