FDA UDI
Not in Commercial Distribution
🇺🇸 United States
TEXAS
DI: 04055207033753
·
Model: 825200841
·
Richard Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TEXAS
- Primary DI
- 04055207033753
- Version / Model
- 825200841
- Catalog Number
- 82520.0841
- Company Name
- Richard Wolf GmbH
- Labeler DUNS
- 315304071
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-26
- Public Version
- 3
- Public Version Date
- 2022-08-19
- Public Version Status
- Update
- Public Device Record Key
- c0210050-55c1-4442-9434-5f7fe7ed7b65
- Distribution End Date
- 2020-03-02
Device Description
BRONCHOSCOPE-TUBE ID 11MM OD 13.2mm, TL 351mm, for use with the optical element 82510.1400 and head systems 825101100 and 825101200, with distal viewing window, graduated, reusable
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KTI | BRONCHOSCOPE ACCESSORY | Ear, Nose, Throat | 874.4680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41126 | Bronchoscopy tube | A hollow cylinder composed of plastic, rubber, or other material that is inserted orally into the trachea to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and secure ventilation during diagnostic or therapeutic bronchoscopy using a flexible bronchoscope. It has a cuff at the distal end, similar to that of a cuffed endotracheal (ET) tube and may be packaged with a connector that attaches to a breathing circuit. It has a large enough bore to accommodate a flexible bronchoscope; this can enhance the safety of the procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04055207033753 | GS1 |
Customer Contacts
- Phone
- +497043350
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 11 | Millimeter |