FDA.report

Busse Hospital Disposables

Primary DI
00849233017269
Brand
Busse Hospital Disposables
Company
ROBERT BUSSE & CO., INC.
Model
8786
Catalog number
8786
Device description
Sterile Pellet INS
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DRCTrocar
FBQTrocar, Gastro-Urology

Product Code Classifications

CodeDeviceSpecialtyClass
DRCTrocarCardiovascular2
FBQTrocar, Gastro-UrologyGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10849233017266PackageGS120In Commercial Distribution
00849233017269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084923301726610849233017266
00849233017269008492330172698492330172690849233017269

GMDN Terms

TermDefinition
Laparoscopic access cannula, single-useA single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments; it may additionally be intended for thoracoscopy whereby the valve may not be required. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
1 (631) 435-4711mail@busseinc.com

Regulatory Flags

DUNS number
002418234
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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10849233013572Busse Hospital Disposables8917R12025-06-23
10849233013497Busse Hospital Disposables28832025-05-06
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10849233013121Busse Hospital DisposablesB84602025-04-23
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10849233012827Busse Hospital Disposables28542025-03-12
10849233012810Busse Hospital DisposablesB17162025-03-11
10849233012780Busse Hospital Disposables28972025-03-04

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00888867500914Arthrex®ARTHREX, INC.DRC2026-03-13
10849233014128Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-12-24
10849233014012Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-09-29
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