FDA UDI
In Commercial Distribution
🇺🇸 United States
WECK
DI: 04026704600779
·
Model: IPN008820
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
35
Basic Information
- Brand Name
- WECK
- Primary DI
- 04026704600779
- Version / Model
- IPN008820
- Catalog Number
- 528236
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 35
- Record Status
- Published
- Publish Date
- 2018-09-15
- Public Version
- 4
- Public Version Date
- 2021-03-10
- Public Version Status
- Update
- Public Device Record Key
- 49ac995b-25aa-49ce-9889-7acb519e89f7
Device Description
VISISTAT 35W NON-STERILE
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
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|
| 35884 | Skin stapler/staple, non-bioabsorbable | A hand-held manual, surgical instrument preloaded with non-bioabsorbable skin staples designed to apply the staples to approximate the free skin edges of an incision or wound. The staples (which may be clip-like) are made of metal [e.g., stainless steel or titanium (Ti)] and intended to be removed once the wound has sufficiently healed. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 44026704600777 | GS1 | Case | 10 | Not in Commercial Distribution | 2020-01-20 |
| Package | 34026704600770 | GS1 | Bag | 10 | Not in Commercial Distribution | 2020-01-20 |
| Primary | 04026704600779 | GS1 | ||||
| Unit of Use | 14026704600776 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 6.5 | Inch |