FDA.reportPublic FDA data

Doctor Nice

Primary DI
08964003163136
Brand
Doctor Nice
Company
B. Ali Impex
Model
786-34G2
Device description
Trocar, gastro-urology 3.5mm, complete set, 1 cannula, 1 Bullet type obturator Item number 786-34G2, SS
Published
2023-11-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
FBQTrocar, Gastro-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBQTrocar, Gastro-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08964003163136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08964003163136089640031631368964003163136

GMDN Terms#

Term, Definition table
TermDefinition
Pellet implantation cannulaA sterile, rigid tube intended for subcutaneous delivery of an implantable drug pellet. The cannula is typically designed with a proximal well/side-hole for pellet loading, and typically includes a trocar blade to assist cannula introduction and a push rod to drive the pellet down the cannula; the implant is not included. This is a single-use device.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"
Ethylene Oxide;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
645802117
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
08964003163853Doctor Nice786-28L102024-01-29
08964003163860Doctor Nice786-30L102024-01-29
08964003163877Doctor Nice786-04G32024-01-29
08964003163884Doctor Nice786-04L2024-01-29
08964003163891Doctor Nice786-03L2024-01-29
08964003163075Doctor Nice786-14786-142023-11-10
08964003163112Doctor Nice786-14G42023-11-10
08964003163129Doctor Nice786-33G22023-11-10
08964003163143Doctor Nice786-14G52023-11-10
08964003163020Doctor Nice786-012023-11-09
08964003163037Doctor Nice786-022023-11-09
08964003163051Doctor Nice786-032023-11-09
08964003163068Doctor Nice786-152023-11-09
08964003163082Doctor Nice786-15/G22023-11-09
08964003163099Doctor Nice786-14/G22023-11-09
08964003163105Doctor Nice786-15G42023-11-09
08964003163150Doctor Nice786-04LB2023-11-09
08964003163167Doctor Nice786-282023-11-09
08964003163174Doctor Nice786-302023-11-09
08964003163181Doctor Nice786-052023-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849233015906Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2026-05-27
00849233014121Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-12-24
10849233014128Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-12-24
00849233014015Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-09-29
10849233014012Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-09-29
00849233013162Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-05-01
00849233013124Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-04-23
10849233013121Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-04-23
00849233012837Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-03-20
10849233012834Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-03-20
00849233012813Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-03-11
10849233012810Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-03-11
00849233012776Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-02-25
10849233012773Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-02-25
00849233012769Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-02-14
10849233012766Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-02-14
00849233012493Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2024-05-22
00849233012516Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2024-05-22
10849233012490Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2024-05-22
10849233012513Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2024-05-22
08964003163853Doctor NiceB. Ali ImpexFBQ2024-01-29
08964003163860Doctor NiceB. Ali ImpexFBQ2024-01-29
08964003163877Doctor NiceB. Ali ImpexFBQ2024-01-29
08964003163884Doctor NiceB. Ali ImpexFBQ2024-01-29
08964003163891Doctor NiceB. Ali ImpexFBQ2024-01-29
00849233011144Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-20
00849233011175Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-16
00849233011229Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-16
10849233011172Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-16
10849233011226Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-16