FDA UDI
In Commercial Distribution
🇺🇸 United States
Aveta Tissue Catch with Suction Tubing
DI: 00850006759101
·
Model: 205-116
·
MEDITRINA, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Aveta Tissue Catch with Suction Tubing
- Primary DI
- 00850006759101
- Version / Model
- 205-116
- Catalog Number
- 205-116
- Company Name
- MEDITRINA, INC.
- Labeler DUNS
- 080570262
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-28
- Public Version
- 1
- Public Version Date
- 2019-12-06
- Public Version Status
- New
- Public Device Record Key
- c72871a4-43f4-4981-99b8-4495a2411777
Device Description
Aveta Tissue Catch with Suction Tubing for use with Aveta System
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
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HIG | Insufflator, Hysteroscopic | Obstetrics/Gynecology | 884.1700 | 2 |
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | 884.1690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63210 | Tissue morcellation system tissue preservation container | A non-sterile, non-powered component of a tissue morcellation system intended to house the system’s tissue filter assembly, to preserve collected tissues prior to histological/pathological analysis. It is a dedicated container designed to be filled with ice, and intended to integrate along the system’s suction line between the system’s handpiece and suction canister. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00850006759200 | GS1 | Carton | 8 | In Commercial Distribution | |
| Primary | 00850006759101 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190372 | 000 |