FDA UDI
In Commercial Distribution
🇺🇸 United States
Michel Wound Clips
DI: 00192896107472
·
Model: 1100-778
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Michel Wound Clips
- Primary DI
- 00192896107472
- Version / Model
- 1100-778
- Catalog Number
- 1100-778
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-14
- Public Version
- 3
- Public Version Date
- 2024-10-03
- Public Version Status
- Update
- Public Device Record Key
- 8be69124-44f0-494d-bc65-798463774914
Device Description
Michel Wound Clips Stainless Steel (100 Per Box)
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
- Yes
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization, Dry Heat Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GDT | STAPLE, REMOVABLE (SKIN) | General, Plastic Surgery | 878.4760 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38143 | General skin wound clip | A metallic surgical instrument intended to be used to approximate the edges of any skin wound (non-dedicated) to facilitate wound healing and/or for the placement of sutures. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00192896107472 | GS1 |
Customer Contacts
- Phone
- +1(800)821-7496
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 18 | Millimeter |