FDA UDI
In Commercial Distribution
🇺🇸 United States
Innomed, Inc.
DI: 00840277122520
·
Model: 8988
·
INNOMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Innomed, Inc.
- Primary DI
- 00840277122520
- Version / Model
- 8988
- Catalog Number
- 8988
- Company Name
- INNOMED, INC.
- Labeler DUNS
- 878427491
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-06
- Public Version
- 2
- Public Version Date
- 2021-11-09
- Public Version Status
- Update
- Public Device Record Key
- 6588f526-24fc-4629-8b25-1ac43567b784
Device Description
Gray Syringe Assist with Ergonomic Handle
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
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| IQG | Adaptor, Holder, Syringe | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62514 | Syringe dispensing gun, reusable | A hand-held, manually-operated device intended to facilitate the infusion/dispensing of a high viscosity fluid or pressurized liquid (e.g., laminar stream) by assisting with the advancement of the syringe plunger. It includes a manually-squeezed lever mechanism (e.g., pistol-like) and is designed to accept a standard syringe (not included) whereby it is intended to increase the amount of force the user can apply to the syringe plunger based on leverage. It is not foot-operated and does not include a rotating crank mechanism. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840277122520 | GS1 |