FDA UDI
In Commercial Distribution
🇺🇸 United States
A-dec
DI: 10194665004460
·
Model: 54.0865.00
·
A-DEC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- A-dec
- Primary DI
- 10194665004460
- Version / Model
- 54.0865.00
- Catalog Number
- 54.0865.00
- Company Name
- A-DEC, INC.
- Labeler DUNS
- 009617473
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-07
- Public Version
- 1
- Public Version Date
- 2022-11-15
- Public Version Status
- New
- Public Device Record Key
- 8105b116-65ed-4247-8709-aeefa258b249
Device Description
Electric LS Package,M20L,Master Matic,OTC
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
- No
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64255 | Barbed polyolefin suture | A single-strand (monofilament), synthetic, non-bioabsorbable thread made from a polyolefin (e.g., polypropylene) intended to approximate the edges of a soft-tissue wound or incision by stitching. It is designed with barbs along its length intended to facilitate tissue approximation by adding tension, a fixation feature (e.g., tab, loop, bidirectional barbs) to eliminate the need to tie a knot, and may include disposable suture application devices [e.g., needle, passer]. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, after which it is cut and removed. It does not include antimicrobial materials. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10194665004460 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143465 | 000 |