FDA UDI
In Commercial Distribution
🇺🇸 United States
FRAZIER
DI: 40653405000144
·
Model: 0033120
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
50
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Basic Information
- Brand Name
- FRAZIER
- Primary DI
- 40653405000144
- Version / Model
- 0033120
- Catalog Number
- 0033120
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2022-12-20
- Public Version
- 2
- Public Version Date
- 2024-07-25
- Public Version Status
- Update
- Public Device Record Key
- d6e68b90-213c-4d02-a841-9a58a860326d
Device Description
FRAZIER Surgical Suction Instrument, 12Fr with Control Vent and Obturator (Bend with Obturator in Place)
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCX | APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35917 | Surgical/emergency suction cannula, non-illuminating, single-use | An atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10653405000143 | GS1 | BOX | 10 | In Commercial Distribution | |
| Primary | 40653405000144 | GS1 | ||||
| Package | 50653405000141 | GS1 | BOX | 50 | In Commercial Distribution | |
| Unit of Use | 00653405000146 | GS1 | ||||
| Previous | 30653405000147 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 12 French Outer Diameter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 90 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 32 Degrees Celsius