FDA UDI
Not in Commercial Distribution
🇺🇸 United States
N/A
DI: 00841036147013
·
Model: SP-1958
·
BIOMET MICROFIXATION, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 00841036147013
- Version / Model
- SP-1958
- Catalog Number
- SP-1958
- Company Name
- BIOMET MICROFIXATION, INC
- Labeler DUNS
- 046189866
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-11
- Public Version
- 4
- Public Version Date
- 2020-07-31
- Public Version Status
- Update
- Public Device Record Key
- fbba2f68-5625-44b6-8563-a4d9db3154d8
- Distribution End Date
- 2020-07-30
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
- Yes
- 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 |
|---|---|---|---|---|
| GCX | APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38749 | Surgical/emergency suction cannula, non-illuminating, reusable | An atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841036147013 | GS1 |
Customer Contacts
- Phone
- +1(904)741-4400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K972074 | 000 |