FDA UDI
In Commercial Distribution
🇺🇸 United States
Gyrus ACMI
DI: 00821925005204
·
Model: 437A
·
Gyrus ACMI, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Gyrus ACMI
- Primary DI
- 00821925005204
- Version / Model
- 437A
- Company Name
- Gyrus ACMI, LLC
- Labeler DUNS
- 007198742
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-12
- Public Version
- 7
- Public Version Date
- 2024-09-02
- Public Version Status
- Update
- Public Device Record Key
- 8c5dad16-46ea-4ce7-81c8-b05ef155deb1
Device Description
Straight Lowsley Tractor Single-Action, Stem Only 21.5 Fr (7.1 mm) With 8 Inch (203 mm) Working Length
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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KOB | CATHETER, SUPRAPUBIC (AND ACCESSORIES) | Gastroenterology, Urology | 876.5090 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32021 | Suprapubic catheter introducer, reusable | A rigid surgical instrument(s) intended to gain percutaneous suprapubic access to the urinary bladder, via the lower abdominal wall, for placement of a drainage catheter (not included). It includes a sharp pointed trocar blade and/or a suprapubic access cannula/sleeve, and is typically made of high-grade stainless steel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00821925005204 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K012153 | 000 |