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
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00199150083879Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-07-30
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00810143908848SURGIPROSSurgipros, LLCGAD2026-07-30
00810143909609SURGIPROSSurgipros, LLCGAD2026-07-30
00810212930343SURGIPROSSurgipros, LLCGAD2026-07-30