FDA UDI
In Commercial Distribution
🇺🇸 United States
Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX
DI: 03701354402201
·
Model: PW C-G-D 90
·
PLASMABIOTICS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX
- Primary DI
- 03701354402201
- Version / Model
- PW C-G-D 90
- Company Name
- PLASMABIOTICS
- Labeler DUNS
- 262972663
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-13
- Public Version
- 1
- Public Version Date
- 2021-05-21
- Public Version Status
- New
- Public Device Record Key
- e2204b22-06ef-4b15-9a1e-79816357e158
Device Description
Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX 90 and i10 series
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61446 | Cochlear electrode array introducer, reusable | A non-sterile, hand-held manual surgical instrument designed to aid insertion of an electrode array into the cochlea during implantation of a cochlear implant. It is typically a thin probe with a clawed distal end mounted on a handle and is made of high-grade stainless steel. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03701354402201 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 34 | Centimeter | |
| Width | 23 | Centimeter | |
| Height | 3 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- .9 – 1.1 Inches of Mercury