FDA UDI
In Commercial Distribution
🇺🇸 United States
WECK
DI: 14026704410238
·
Model: IPN002004
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
6
Basic Information
- Brand Name
- WECK
- Primary DI
- 14026704410238
- Version / Model
- IPN002004
- Catalog Number
- 001205
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2015-10-16
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- cb3299d0-019e-4105-b0b1-41e657ab738c
Device Description
HORIZON TI SMALL RED 24 Clips/Pouch
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
- MR Conditional
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FZP | CLIP, IMPLANTABLE | General, Plastic Surgery | 878.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15076 | Rigid intubation laryngoscope, reusable | A hand-held device intended to be used by anaesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It has a handle containing batteries to power its light (a small built-in light bulb or fibreoptic light) for airway illumination, and a curved or straight blade of various designs and lengths that can be hinged/interchanged or integral. Some types can be magnetic resonance imaging (MRI) compatible. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 44026704410239 | GS1 | Case | 6 | In Commercial Distribution | |
| Package | 24026704410235 | GS1 | Box | 25 | In Commercial Distribution | |
| Primary | 14026704410238 | GS1 | ||||
| Unit of Use | 04026704410231 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K982313 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 2.87 | Millimeter | |
| Device Size Text, specify | Horizon Small, Wide Ligating Clips, 4-Pack, Titanium | ||
| Length | 3.68 | Millimeter |