FDA UDI
In Commercial Distribution
🇺🇸 United States
n.a.
DI: 04048551046739
·
Model: 10350LE
·
Karl Storz GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- n.a.
- Primary DI
- 04048551046739
- Version / Model
- 10350LE
- Company Name
- Karl Storz GmbH & Co. KG
- Labeler DUNS
- 315731430
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 44478853-3f04-4746-8f57-5a642839eb5f
Device Description
Optical Biopsy Forceps
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | Ear, Nose, Throat | 874.4680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32637 | Rigid bronchoscopic biopsy forceps, reusable | A rigid manual instrument intended to perform through a compatible bronchoscope to obtain specimens of the bronchi and/or the lungs during endoscopy for histopathological examination. It is typically constructed as a very long instrument with one sliding and one stationary rod whose distal ends are equipped with scissors-like cups with a cutting edge around their rim which are operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through an artificial orifice of the body or the working channel of the endoscope. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048551046739 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K943700 | 000 |