FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 04048551051979
·
Model: 11605FO
·
Karl Storz GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 04048551051979
- Version / Model
- 11605FO
- 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
- 2014-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- a35d184f-a27a-42b4-8057-b048e7d21594
Device Description
Obturator for 11605 FK
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, Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HFA | Amnioscope, Transabdominal (Fetoscope) (And Accessories) | Obstetrics/Gynecology | 884.1600 | f |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35692 | Rigid endoscope obturator | An endoscopic device that is a component of a rigid endoscope assembly that has a distally rounded, solid, head or end that is placed into the sheath of a rigid endoscope in order to fill out the sheath's lumen (open end), thereby assisting its insertion into the body and protecting against damage to the patient. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048551051979 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 68 | Centimeter |