FDA UDI
In Commercial Distribution
🇺🇸 United States
UNISILK V
DI: 16285379148886
·
Model: SD2007
·
UNITED MEDICAL INDUSTRIES CO. LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
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Basic Information
- Brand Name
- UNISILK V
- Primary DI
- 16285379148886
- Version / Model
- SD2007
- Catalog Number
- SD2007
- Company Name
- UNITED MEDICAL INDUSTRIES CO. LTD
- Labeler DUNS
- 535040901
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2020-04-30
- Public Version
- 2
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 80cf920a-1ae1-4c48-959d-b45943954783
Device Description
Virgin Silk, Natural Non-Absorbable Surgical Sututres / Ligatures
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| GAP | Suture, Nonabsorbable, Silk | General, Plastic Surgery | 878.5030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13910 | Silk suture | A natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 06285379148889 | GS1 | ||||
| Primary | 16285379148886 | GS1 |
Customer Contacts
- Phone
- +966112650665
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042282 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 0.04 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius