FDA UDI
In Commercial Distribution
🇺🇸 United States
PUMA-G System™
DI: 00860312001559
·
Model: 0010046
·
Coaptech, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- PUMA-G System™
- Primary DI
- 00860312001559
- Version / Model
- 0010046
- Catalog Number
- 0010170
- Company Name
- Coaptech, Inc.
- Labeler DUNS
- 080322442
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-29
- Public Version
- 2
- Public Version Date
- 2025-05-14
- Public Version Status
- Update
- Public Device Record Key
- 158cb669-448a-4cec-a6e9-50d178cdd801
Device Description
Percutaneous Ultrasound Gastrostomy (PUG) System Guidewire
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| KGC | Tube, Gastro-Enterostomy | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46691 | Gastro-urological guidewire, single-use | A metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10860312001556 | GS1 | Carton | 2 | In Commercial Distribution | |
| Primary | 00860312001559 | GS1 | ||||
| Package | 00850026037289 | GS1 | Shipper Box | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- 1 443 574 6934
- [email protected]