FDA UDI
In Commercial Distribution
🇺🇸 United States
8.5 x 50mm CANN EXTENSION FASTENER
DI: 00810097802056
·
Model: 101-85050
·
Osteocentric Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- 8.5 x 50mm CANN EXTENSION FASTENER
- Primary DI
- 00810097802056
- Version / Model
- 101-85050
- Catalog Number
- 101-85050
- Company Name
- Osteocentric Technologies, Inc.
- Labeler DUNS
- 089645059
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-13
- Public Version
- 3
- Public Version Date
- 2024-08-09
- Public Version Status
- Update
- Public Device Record Key
- e09108ad-40a0-408b-90c0-ae1aa7883cd0
Device Description
8.5 x 50mm CANN EXTENSION FASTENER
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
- 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 |
|---|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 888.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46632 | Endoscopic electrosurgical submucosal lift/resection set | A collection of devices designed to be used during an endoscopic mucosal resection procedure to: 1) lift a section of diseased mucosa by injection of a submucosal lifting solution; and 2) resect the lesion using monopolar electrosurgical energy; it may in addition include devices designed to perform vacuum elevation of the lesion to supplement submucosal lifting. It includes a submucosal injection needle, an electrosurgical electrode (e.g., polyp snare), and might include additional supportive devices such as a dye spray catheter and endoscope suction cap. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810097802056 | GS1 |
Customer Contacts
- Phone
- 1-800-969-0639
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221332 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 8.5 | Millimeter | |
| Length | 50 | Millimeter |