FDA UDI
In Commercial Distribution
🇺🇸 United States
american catheter CORP
DI: B80291000
·
Model: 9100
·
American Catheter Corp.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- american catheter CORP
- Primary DI
- B80291000
- Version / Model
- 9100
- Company Name
- American Catheter Corp.
- Labeler DUNS
- 117322103
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-20
- Public Version
- 1
- Public Version Date
- 2023-06-28
- Public Version Status
- New
- Public Device Record Key
- 7994c7bb-bced-4667-90e2-6561621e05b8
Device Description
laparoscopic cholangiogram catheter
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GBZ | Catheter, Cholangiography | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60437 | Interventional radiology percutaneous-access kit, single-use | A collection of various instruments/devices (e.g., introducer sheath, dilator, guides, cannula, needle, angiographic catheter) intended to be used for percutaneous body-access to facilitate a radiological image-guided interventional radiology or surgical procedure [e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures, ultrasound-guided spinal surgery]. Some types are designed to function as a channel to facilitate the introduction of radiological image guidance devices (e.g., ultrasound probe/transducer) [not included]. It does not contain pharmaceuticals. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B80291000 | HIBCC |