FDA UDI
In Commercial Distribution
🇺🇸 United States
ACE
DI: 00614950013586
·
Model: 0031717
·
ACE SURGICAL SUPPLY CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ACE
- Primary DI
- 00614950013586
- Version / Model
- 0031717
- Catalog Number
- 0031717
- Company Name
- ACE SURGICAL SUPPLY CO., INC.
- Labeler DUNS
- 042763706
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-13
- Public Version
- 1
- Public Version Date
- 2019-10-21
- Public Version Status
- New
- Public Device Record Key
- 8e624ca0-3bf2-4809-887c-a4d9bdc35523
Device Description
CUSTOM FOOT PEDAL FOR AIR DRILL CONNECTION
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| HWE | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63197 | Endoscopic irrigation/aspiration foot-pedal | A manual, foot-operated device designed to be used in conjunction with a dedicated irrigation tubing set and a disposable syringe to facilitate displacement of the syringe plunger for irrigation of an endoscopic site. It is intended to house the syringe which is intended to be connected to a tubing set with an appropriate inflow/outflow valve, whereby lifting the foot-pedal fills the syringe from an irrigation solution source, and pressing the foot-pedal displaces fluid from the syringe. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00614950013586 | GS1 |
Customer Contacts
- Phone
- +1(508)588-3100 ext. 214
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- No special storage conditions required