FDA.reportPublic FDA data

Extraction Kit

Primary DI
03665039005630
Brand
Extraction Kit
Company
PRINCE MEDICAL
Model
B-4815
Catalog number
B-4815
Device description
Endoline PUNC and Endoline VIPER
Published
2024-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GADRetractor
LTIImplant, Intragastric For Morbid Obesity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1
LTIImplant, Intragastric For Morbid ObesityUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03665039005630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03665039005630036650390056303665039005630

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal needle catheterA sterile, flexible tube with a retractable needle at the distal end intended for puncturing an inflated balloon within the gastrointestinal tract (e.g., appetite-suppression gastric balloon) to enable its removal. It is introduced through an endoscope and the needle action controlled by a handle at the proximal end. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
569442924
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03665039001656Endoline VIPERSN3980718SN39807182024-01-30
03665039001663Endoline PUNCSN4000718SN40007182024-01-30
03665039002417CATHETER POUR CYSTOMETRIE 2 VOIES CH 6VS1480640VS14806402021-10-29
03665039010832CATHETER POUR CYSTOMETRIE 2 VOIES CH 6VS1480640VS14806402021-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091339ELMED INCORPORATEDELMED INCORPORATEDGAD2026-06-09
00840277133670Innomed, Inc.INNOMED, INC.GAD2026-06-09
04049047155324GimmiGimmi GmbHGAD2026-06-08
G453PM1580030BC0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-06-08
00191506049232Orbera™BOSTON SCIENTIFIC CORPORATIONLTI2026-06-04
00846159040524SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040531SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040548SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040555SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040562SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040579SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040586SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040593SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040609SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040616SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040623SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00841536147230ThompsonThompson Surgical Instruments, Inc.GAD2026-06-03
00846159040388SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040395SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040401SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040418SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040425SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040432SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040449SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040456SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040463SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040470SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040487SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040494SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040500SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03