FDA UDI
In Commercial Distribution
🇺🇸 United States
BOSS Instruments
DI: 00888515254572
·
Model: 98-6185
·
BOSS INSTRUMENTS, LTD., INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BOSS Instruments
- Primary DI
- 00888515254572
- Version / Model
- 98-6185
- Catalog Number
- 98-6185
- Company Name
- BOSS INSTRUMENTS, LTD., INC.
- Labeler DUNS
- 848522678
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-28
- Public Version
- 1
- Public Version Date
- 2024-03-07
- Public Version Status
- New
- Public Device Record Key
- 088a562b-d6d9-4091-86f2-851c371bf85e
Device Description
Price Muscle Biopsy Clmp, dbl prong tips, 8mm jaw
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
- 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 |
|---|---|---|---|---|
| HXD | CLAMP | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45416 | Muscle biopsy clamp | A sterile manual gripping device designed to secure muscle tissue in order to obtain a biopsy sample. It is used to hold a muscle fibre specimen in a longitudinal position to help preserve the original orientation of the fibres, from the sampling stage through analysis of the tissue. It will typically be designed so that, with the in situ sample, it can fit into an automated histological processing/analysing machine. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888515254572 | GS1 |
Customer Contacts
- Phone
- +1(540)832-5000
- [email protected]