FDA UDI
In Commercial Distribution
🇺🇸 United States
TruTorq Adaptor Sterile, Single Use
DI: 00857676008294
·
Model: 14 Nm
·
Eca Medical Instruments
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TruTorq Adaptor Sterile, Single Use
- Primary DI
- 00857676008294
- Version / Model
- 14 Nm
- Catalog Number
- 803-003
- Company Name
- Eca Medical Instruments
- Labeler DUNS
- 084330422
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-14
- Public Version
- 3
- Public Version Date
- 2023-07-25
- Public Version Status
- Update
- Public Device Record Key
- ba6f3bbd-5163-437a-ab5b-2d9dba7b31f0
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63133 | Surgical torque wrench, single-use | A sterile hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857676008294 | GS1 |