FDA UDI
In Commercial Distribution
🇺🇸 United States
MANI Sutures Silk
DI: 04546951400545
·
Model: 3855S
·
MANI, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MANI Sutures Silk
- Primary DI
- 04546951400545
- Version / Model
- 3855S
- Catalog Number
- 3855S
- Company Name
- MANI, INC.
- Labeler DUNS
- 690622428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-04
- Public Version
- 9
- Public Version Date
- 2023-10-02
- Public Version Status
- Update
- Public Device Record Key
- 13d00dfb-a8a9-4e85-a7c8-fd9c523d2819
Device Description
MANI Ophthalmic Sutures
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Primary | 04546951400545 | GS1 | ||||
| Package | 14546951400542 | GS1 | 12 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Needle Length 16.0mm | ||
| Device Size Text, specify | Suture Length 30cm |