FDA.reportPublic FDA data

DUFNER Instrumente GmbH

Primary DI
04063763202018
Brand
DUFNER Instrumente GmbH
Company
DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik
Model
20943-60
Device description
MICTEC Spray nozzle with bellows for Talcum powder, autoclavable, Ø 5 mm, tube double angled, 300 mm working length consisting of:
Published
2024-03-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002877000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002877000MICTEC ENDOSCOPES AND ACCESSORIESDufner Instrumente GmbH2001-02-05GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04063763202018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04063763202018040637632020184063763202018

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic suction valve, reusableA non-sterile device intended to be fitted to an endoscope suction channel to enable the operator to control suction whist preventing inflow of air. It is in the form of an attachable valve that controls (opens/closes) the suction channel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
327980801
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04063763186493DUFNER Instrumente GmbH26943-022024-03-11
04063763186554DUFNER Instrumente GmbH26943-062024-03-11
04063763200533DUFNER Instrumente GmbH20941-302024-03-11
04063763200601DUFNER Instrumente GmbH20943-042024-03-11
04063763200793DUFNER Instrumente GmbH20941-012024-03-11
04063763201790DUFNER Instrumente GmbH20943-542024-03-11
04063763202070DUFNER Instrumente GmbH20943-612024-03-11
04063763156168DUFNER Instrumente GmbH15-11181-202024-03-11
04063763157820DUFNER Instrumente GmbH12-06110-062024-03-11
04063763158247DUFNER Instrumente GmbH04-11020-032024-03-11
04063763160318DUFNER Instrumente GmbH04-11020-102024-03-11
04063763177446DUFNER Instrumente GmbH27913-112024-03-11
04063763178986DUFNER Instrumente GmbH27996-012024-03-11
04063763180316DUFNER Instrumente GmbH12881-232024-03-11
04063763180330DUFNER Instrumente GmbH12881-322024-03-11
04063763186462DUFNER Instrumente GmbH26943-002024-03-11
04063763186707DUFNER Instrumente GmbH26944-022024-03-11
04063763186714DUFNER Instrumente GmbH26944-032024-03-11
04063763189661DUFNER Instrumente GmbH26943-212024-03-11
04063763199684DUFNER Instrumente GmbH20907-172024-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422745MillenniumAvalign Technologies, Inc.GCJ2026-08-03
00190776422752MillenniumAvalign Technologies, Inc.GCJ2026-08-03
04026704934812TELEFLEXTELEFLEX INCORPORATEDGCJ2026-08-03
B382SD4131490Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD4162910Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD49245120Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD55670280Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56325330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56400150Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56534210Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD567910130Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56914330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
00190776421960MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00190776422325MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00888867498105Arthrex®ARTHREX, INC.GCJ2026-07-31
14026704921741TELEFLEXTELEFLEX INCORPORATEDGCJ2026-07-31
B382SD13768130Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD13798130Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD14678780Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD15378970Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD15458990Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD161090Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD169920Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD30109760Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
00198506092183ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506093562ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506093838ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-07-29
00198506092435ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-28