FDA UDI
In Commercial Distribution
🇺🇸 United States
Aveta Auto Disposable Resecting Device
DI: 00850006759545
·
Model: 215-010
·
MEDITRINA, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Aveta Auto Disposable Resecting Device
- Primary DI
- 00850006759545
- Version / Model
- 215-010
- Catalog Number
- 215-010
- Company Name
- MEDITRINA, INC.
- Labeler DUNS
- 080570262
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-11
- Public Version
- 1
- Public Version Date
- 2021-02-19
- Public Version Status
- New
- Public Device Record Key
- 4fbd7143-5a5f-4707-b6f4-49b5db92a29e
Device Description
Aveta Auto Disposable Resecting Device 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
- Yes
- 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 |
|---|---|---|---|---|
| 46732 | Tissue morcellation system handpiece, line-powered | A hand-held component of a tissue morcellation system intended to be used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body during surgery. It consists of a high-speed rotating blade in a holder and is connected to a line-powered control unit for the transfer of electrical energy or rotational power (via an electrical or remote drive cable); a handpiece obturator, and a disposable remote drive cable may be included. Resected tissue may be removed through suction or manually with a grasping instrument. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00850006759552 | GS1 | shelf carton | 3 | In Commercial Distribution | |
| Primary | 00850006759545 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190372 | 000 |