FDA UDI
In Commercial Distribution
🇺🇸 United States
SPIRO
DI: 07350061231060
·
Model: 705
·
Fogless International AB
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Basic Information
- Brand Name
- SPIRO
- Primary DI
- 07350061231060
- Version / Model
- 705
- Catalog Number
- 705-10
- Company Name
- Fogless International AB
- Labeler DUNS
- 356432815
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2018-03-31
- Public Version
- 4
- Public Version Date
- 2020-07-23
- Public Version Status
- Update
- Public Device Record Key
- 0567393e-e531-4355-989b-97444febd7c9
Device Description
SPIRO Tweezers
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
- Yes
- PM Exempt
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42500 | Dressing/utility forceps, tweezers-like, reusable | A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It typically has a tweezers-like design with two blades joined at the proximal (non-working) end with variously designed tips at the working end. It is made of metal and/or plastic materials and is available in various sizes. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07350061231077 | GS1 | Zip-Lock Bag | 5 | In Commercial Distribution | |
| Primary | 07350061231060 | GS1 | ||||
| Unit of Use | 07350061231312 | GS1 |
Customer Contacts
- Phone
- +4636144100
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a dark and dry environment at normal indoor room temperature