FDA UDI
In Commercial Distribution
🇺🇸 United States
ACE
DI: 00614950023707
·
Model: 1010036
·
ACE SURGICAL SUPPLY CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ACE
- Primary DI
- 00614950023707
- Version / Model
- 1010036
- Catalog Number
- 1010036
- 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
- 2019-10-24
- Public Version
- 1
- Public Version Date
- 2019-11-01
- Public Version Status
- New
- Public Device Record Key
- 7e30ec80-de65-424b-a8e7-eeb7ff3a6954
Device Description
RONGEUR MICRO FRIEDMAN 5-1/2" 14CM
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
- 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 |
|---|---|---|---|---|
| EMH | FORCEPS, RONGEUR, SURGICAL | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15713 | Dental rongeur | A strongly constructed dental instrument that is used in the removal of the sharp edges of the alveolar crest of the bone following tooth extraction. It has a forceps or pliers-like design terminating at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws that bite (cut) through the bone tissue. It is made of high-grade stainless steel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00614950023707 | GS1 |
Customer Contacts
- Phone
- +1(800)441-3100
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 5.5 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- No special storage conditions required