FDA UDI
In Commercial Distribution
🇺🇸 United States
Syneture
DI: 10884521706804
·
Model: US1725
·
Covidien LP
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Syneture
- Primary DI
- 10884521706804
- Version / Model
- US1725
- Company Name
- Covidien LP
- Labeler DUNS
- 058614483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-20
- Public Version
- 7
- Public Version Date
- 2023-10-12
- Public Version Status
- Update
- Public Device Record Key
- 1b10c432-57a7-4e85-a506-2dd0622756a7
Device Description
(1) 88863001-72, (1) 88863008-31, (1) 88863008-51, (1) 88863256-51, (2) 88863369-51, (2) CL-14-MG, (1) CL-5-M, (2) CL-843, (1) CL-844, (1) CL-965, (2) SM-5678, (1) VP-702-MX, (1) VP-733-MX, (1) VP-761
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 | 30884521706808 | GS1 | PACK_OR_INNER_PACK | 3 | In Commercial Distribution | |
| Primary | 10884521706804 | GS1 | ||||
| Package | 20884521706801 | GS1 | CASE | 2 | In Commercial Distribution |
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