FDA UDI
In Commercial Distribution
🇺🇸 United States
Raspatory Straight
DI: 09120047306574
·
Model: HB 3626
·
I.T.S. GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Raspatory Straight
- Primary DI
- 09120047306574
- Version / Model
- HB 3626
- Catalog Number
- HB 3626
- Company Name
- I.T.S. GmbH
- Labeler DUNS
- 303456917
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-13
- Public Version
- 1
- Public Version Date
- 2018-12-14
- Public Version Status
- New
- Public Device Record Key
- 4691c9a7-08de-4cbb-8a56-31e3f9963182
Device Description
Raspatory Straight, 6mm, 19cm
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13287 | Bone raspatory | A hand-held, manually-operated, surgical instrument with a profiled, forward-scraping edge (sharp or blunt, sometimes double-sided) used to elevate and/or detach the periosteum (membrane of fibrous connective tissue tightly surrounding bone) from the underlying bone by a pushing action usually applied along the longitudinal axis of the bone. It is typically a one-piece instrument made of high-grade stainless steel; it is available in a wide variety of sizes and blade designs [e.g., slender or robust, curved, spoon-shaped, or flat (chisel-like)]. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09120047306574 | GS1 |