FDA UDI
In Commercial Distribution
🇺🇸 United States
PUMA-G System™
DI: 10850026037132
·
Model: 0010323
·
Coaptech, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- PUMA-G System™
- Primary DI
- 10850026037132
- Version / Model
- 0010323
- Catalog Number
- 0010366
- Company Name
- Coaptech, Inc.
- Labeler DUNS
- 080322442
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-13
- Public Version
- 2
- Public Version Date
- 2023-12-13
- Public Version Status
- Update
- Public Device Record Key
- 6827d857-f6a1-4581-98f5-9a0447625099
Device Description
External Magnet in Case
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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGC | Tube, Gastro-Enterostomy | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64056 | Ultrasound-guided gastrostomy system magnet | A hand-held device intended to be placed non-invasively on the anterior abdominal wall to attract the stomach wall via a magnet at the distal end of an in situ ultrasound-guided gastrostomy system catheter (not included), to facilitate a gastrostomy. The optimal placement of the catheter tip without intervention of other anatomical structures (e.g., organs, vessels) is achieved using an ultrasound imaging system (not included). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10850026037132 | GS1 | ||||
| Direct Marking | 00850026037135 | GS1 | ||||
| Package | 00850026037142 | GS1 | Shipper Box | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 1 443 574 6934
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store away from ferromagnetic material
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 25 – 75 Percent (%) Relative Humidity