FDA UDI
In Commercial Distribution
🇺🇸 United States
MACI Arthroscopic Instruments
DI: 00850037506217
·
Model: 82033
·
VERICEL CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MACI Arthroscopic Instruments
- Primary DI
- 00850037506217
- Version / Model
- 82033
- Catalog Number
- N/A
- Company Name
- VERICEL CORPORATION
- Labeler DUNS
- 079745570
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-26
- Public Version
- 1
- Public Version Date
- 2024-09-03
- Public Version Status
- New
- Public Device Record Key
- e5c47ed5-5387-426d-9929-451f87a4bb33
Device Description
15mm V-Shuttle and Two-Pack MACI Applicator Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| HWQ | Passer | Orthopedic | 888.4540 | 1 |
| HXG | Tamp | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67306 | Orthopaedic graft inserter, single-use | A hand-held manual surgical instrument designed to push a cartilage or bone graft into a position from which the graft can be delivered into a chondral defect [e.g., during anterior cruciate ligament (ACL) reconstruction surgery]. This device is available in a variety of designs, such as a plunger made of high-grade materials [e.g., medical grade plastic, stainless steel or titanium (Ti)] used to advance the graft through a cannula, or a similar tubular access device (e.g., bone graft funnel), and into place; it is also available in a variety of sizes. It may additionally be supplied with accessories (e.g., swabs). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850037506217 | GS1 |