DEVICE: NA (04055207033517)
Device Identifier (DI) Information
NA
825103520
In Commercial Distribution
82510.3520
Richard Wolf GmbH
825103520
In Commercial Distribution
82510.3520
Richard Wolf GmbH
BRONCHOSCOPE-TUBE ID 3.7MM by Nicolai-Mantel, OD 4.3mm, TL 200mm, without proximal light connection, without distal viewing window, reusable
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Rigid bronchoscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the trachea, primary bronchi, and upper regions of the lungs. It is inserted through the mouth during the procedure called bronchoscopy. The inserted portion has an internal lumen sufficiently large to permit free respiration of the patient. The anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. It is used to diagnose lung infections, pneumonia, lung cancer, and allows physicians to view the upper regions of the lungs and take biopsies and samples of secretions. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KTI | BRONCHOSCOPE ACCESSORY |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
No
Yes
CLOSE
Yes
Sterilization Method [?] |
---|
Hydrogen Peroxide |
Moist Heat or Steam Sterilization |
Ethylene Oxide |
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Lumen/Inner Diameter: 3.7 Millimeter |
Device Record Status
12dba96e-a781-49c6-93cd-62e6783f4464
March 29, 2018
2
September 26, 2016
March 29, 2018
2
September 26, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+497043350
info@richard-wolf.com
info@richard-wolf.com