FDA UDI
In Commercial Distribution
🇺🇸 United States
MTI
DI: 10840118423318
·
Model: 329-00-244
·
Medical Technology Industries, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MTI
- Primary DI
- 10840118423318
- Version / Model
- 329-00-244
- Catalog Number
- 329-00-244
- Company Name
- Medical Technology Industries, Inc.
- Labeler DUNS
- 053947946
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-03
- Public Version
- 1
- Public Version Date
- 2020-02-11
- Public Version Status
- New
- Public Device Record Key
- 249c8414-e4c4-4788-9f67-8586c6a80d1c
Device Description
Stool, Hydraulic Pump w/Ergo Backrest, ULTRA-GARNET
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FZM | Stool, Operating-Room | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32307 | Operating room stool | A seat, usually padded and height-adjustable, intended to be occupied by operating room (OR) staff during surgical procedures as an alternative to standing; it does not include support for the back or arms. It is intended to be used in operating theatres or clean-rooms and is therefore constructed so that it is easy to clean to help minimize risk of contamination. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10840118423318 | GS1 |
Customer Contacts
- Phone
- 801-887-5114
- [email protected]