FDA UDI
In Commercial Distribution
🇺🇸 United States
Boss Instruments
DI: 00888515043657
·
Model: 35-9073
·
BOSS INSTRUMENTS, LTD., INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Boss Instruments
- Primary DI
- 00888515043657
- Version / Model
- 35-9073
- Catalog Number
- 35-9073
- Company Name
- BOSS INSTRUMENTS, LTD., INC.
- Labeler DUNS
- 848522678
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-20
- Public Version
- 3
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- 5030a53d-19c4-43b2-98a1-71cd6fe236f6
Device Description
Hasson Type Cannula, 10mm piston value, removeable suture ties
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
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, cutting & coagulation & accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46241 | Surgical support tape, bioabsorbable | A band or cord intended to be used during surgery for the approximation, fixation, retraction, stabilization, reinforcement, and/or suspension of internal anatomical structures. The device is typically made of a synthetic material (e.g., polyglactin, polydioxanone), is available in a variety of lengths, and may include a needle. This tape is left in situ. This is a device made of material that is chemically degraded or absorbed via natural body processes. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888515043657 | GS1 |
Customer Contacts
- Phone
- +1(540)832-5000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040855 | 000 |