FDA UDI
In Commercial Distribution
🇺🇸 United States
ACE
DI: 00614950022250
·
Model: 0703008
·
ACE SURGICAL SUPPLY CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ACE
- Primary DI
- 00614950022250
- Version / Model
- 0703008
- Catalog Number
- 0703008
- 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
- 64f56541-019f-4f31-928b-5ff68c8a20c2
Device Description
CONDYLAR REPOSITIONING INSTRUMENT
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
- 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 |
|---|---|---|---|---|
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45251 | Orthodontic appliance relief material | A device used to cover the offending sharp edges of an orthodontic appliance being worn by the user in order to provide relief from the discomforts that this can cause. It can be presented as a sheet, strip, or rod and is typically made of a mouldable wax or silicone material that is easy to manipulate with the fingers in order to cover the offending protrusions of the orthodontic appliance that are causing irritations in the patient's mouth. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00614950022250 | 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