FDA UDI
In Commercial Distribution
🇺🇸 United States
GRAFTMAX
DI: 10845854042236
·
Model: KS-BTB
·
Conmed Corporation
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- GRAFTMAX
- Primary DI
- 10845854042236
- Version / Model
- KS-BTB
- Catalog Number
- KS-BTB
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 7
- Public Version Date
- 2024-04-05
- Public Version Status
- Update
- Public Device Record Key
- 713c180e-6c4a-46d2-b7fd-2dbda7082f0b
Device Description
GraftMax Button BTB (Bone Tendon Bone)
Device Characteristics
- Single Use
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| MBI | FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE | Orthopedic | 888.3040 | 2 |
| GAT | Suture, nonabsorbable, synthetic, polyethylene | General, Plastic Surgery | 878.5000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45062 | Tendon/ligament bone anchor, non-bioabsorbable | A non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)]. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10845854042236 | GS1 | ||||
| Package | 20845854042233 | GS1 | Box | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070780 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP DRY