FDA UDI
In Commercial Distribution
🇺🇸 United States
PDO Max Cannulas
DI: 00850018324472
·
Model: CAN21100
·
Max Pdo Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PDO Max Cannulas
- Primary DI
- 00850018324472
- Version / Model
- CAN21100
- Catalog Number
- CAN21100
- Company Name
- Max Pdo Inc
- Labeler DUNS
- 043570058
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-24
- Public Version
- 1
- Public Version Date
- 2021-04-01
- Public Version Status
- New
- Public Device Record Key
- be063316-97c5-4bbc-acf1-89f8513642cf
Device Description
Cannula, Surgical, General and Plastic Surgery
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
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52751 | Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use | A long flexible or rigid tube with an atraumatic tip intended to be used during an endoscopic/laparoscopic procedure to provide access for the administration of a haematological concentrate and/or haemostatic agent (e.g., thrombin, platelet concentrate, polysaccharide) to a bleeding surgical site, typically to facilitate haemostasis and healing, in conjunction with an applicator such as a syringe [not included]. It is designed to be inserted into the body percutaneously, via a port or endoscope/laparoscope. It may have a single or dual-channel(s) for administration of one or two agent(s); a channel for connection to a gas pump for spraying may be incorporated. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850018324472 | GS1 |