FDA UDI
In Commercial Distribution
🇺🇸 United States
XO Button
DI: 10845854036341
·
Model: PS8834
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- XO Button
- Primary DI
- 10845854036341
- Version / Model
- PS8834
- Catalog Number
- PS8834
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-14
- Public Version
- 2
- Public Version Date
- 2022-09-22
- Public Version Status
- Update
- Public Device Record Key
- ebf271e3-e144-4c1b-b826-52a55a7593bf
Device Description
XO Button Holder
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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FSM | TRAY, SURGICAL, INSTRUMENT | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56649 | Tendon/ligament graft preparation station | An assembly of devices designed to provide the operator with a workstation for the preparation and pretensioning of a ligament and/or tendon graft prior to implantation. It typically consists of a work base to provide a stable platform on which the graft can be treated, various types of adjustable and fixed posts including soft tissue clamps and tensioning devices, a graft sizing block, and tools to hold and tension a graft (e.g., an Allen key). It may be used for a variety of bone-tendon-bone and soft tissue grafts such as semitendinosus patellar tendon, quadriceps tendon, or patellar tendon grafts for anterior cruciate ligament (ACL) reconstruction. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10845854036341 | GS1 | ||||
| Direct Marking | 20845854036348 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]