FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Syneture
DI: 10884521622142
·
Model: US1720
·
Covidien LP
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Syneture
- Primary DI
- 10884521622142
- Version / Model
- US1720
- Company Name
- Covidien LP
- Labeler DUNS
- 058614483
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-22
- Public Version
- 5
- Public Version Date
- 2023-03-24
- Public Version Status
- Update
- Public Device Record Key
- bf0ea820-4f67-4de3-af94-5e8b2639cf95
- Distribution End Date
- 2021-02-11
Device Description
Custom Suture Pack, (2) 88862617-53, (1) 88863182-31, (1) 88863185-51, (2) 88863256-41, (2) CL-924, (1) CL-953, (3) CS-16-M, (3) S-282, (1) SL-693
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
- 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 |
|---|---|---|---|---|
| OVN | Suture kit | General, Plastic Surgery | 878.4830 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13892 | Suture kit, medicated | A collection of sterile instruments, dressings, and pharmaceuticals necessary to perform a suturing procedure. It typically includes a disinfectant, needles and various threads (sutures used to join the edges of a wound or incision by stitching), drapes, swabs, needle holder, and other single-use disposable devices. This device may be used in a wide variety of clinical settings and some types may be used for the removal 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 |
|---|---|---|---|---|---|---|
| Package | 20884521622149 | GS1 | PACK_OR_INNER_PACK | 6 | Not in Commercial Distribution | 2021-02-11 |
| Primary | 10884521622142 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 130 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit