FDA UDI
In Commercial Distribution
🇺🇸 United States
Xpert Hand
DI: 03700569664978
·
Model: CAT1.5L14D
·
NEWCLIP TECHNICS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Xpert Hand
- Primary DI
- 03700569664978
- Version / Model
- CAT1.5L14D
- Catalog Number
- CAT1.5L14D
- Company Name
- NEWCLIP TECHNICS
- Labeler DUNS
- 263281904
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-16
- Public Version
- 1
- Public Version Date
- 2026-04-24
- Public Version Status
- New
- Public Device Record Key
- 201810db-f56c-4398-8f65-50aba763b982
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66927 | Public respirator body | A form-shaped filtering mask designed to be fitted with an appropriate filter(s) [not included] and placed over the nose and mouth of a member of the general public to permit normal breathing while protecting the wearer from large and small particles when considered necessary (e.g., viral epidemic). It is designed to create an airtight seal against the user’s face, and typically includes ties/headstraps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03700569664978 | GS1 |