FDA UDI
In Commercial Distribution
🇺🇸 United States
AC DEVICE
DI: 05060433600104
·
Model: LD150
·
Lockdown Medical Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AC DEVICE
- Primary DI
- 05060433600104
- Version / Model
- LD150
- Catalog Number
- LD150
- Company Name
- Lockdown Medical Ltd
- Labeler DUNS
- 211167885
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-30
- Public Version
- 4
- Public Version Date
- 2021-11-23
- Public Version Status
- Update
- Public Device Record Key
- 3ad0b06c-cf43-4b18-833f-f2a7c1d103f1
Device Description
Lockdown 15cm Acromiaclavicular (AC) Device
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HTN | Washer, Bolt Nut | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47030 | Ligament graft, synthetic polymer | An implantable, non-bioabsorbable device made of synthetic polymer materials (e.g., polyester) intended to be used to replace a missing or damaged ligament to restore natural function. Some types may in addition include a metal anchoring component (e.g., staple, screw) for fixation onto bone; disposable devices associated with implantation may be included. Also referred to as a ligament prosthesis, it is commonly used for ligament reconstruction in the knee [e.g., patellofemoral ligament, anterior cruciate ligament (ACL)] or shoulder (e.g., glenohumeral ligament) joints. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060433600104 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K091207 | 000 |