FDA UDI
In Commercial Distribution
🇺🇸 United States
MANI Sutures Nylon
DI: 04546951400569
·
Model: 3854S
·
MANI, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MANI Sutures Nylon
- Primary DI
- 04546951400569
- Version / Model
- 3854S
- Catalog Number
- 3854S
- 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
- 8
- Public Version Date
- 2021-10-18
- Public Version Status
- Update
- Public Device Record Key
- 9e040221-2746-480e-8f77-2858c74045fa
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 |
|---|---|---|---|---|
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | General, Plastic Surgery | 878.5020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38000 | Nylon suture, non-bioabsorbable, monofilament | A single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) 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. The thread provides temporary wound support until the wound sufficiently heals. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04546951400569 | GS1 | ||||
| Package | 14546951400566 | GS1 | 12 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Needle Length 11.0mm | ||
| Device Size Text, specify | Suture Length 45cm |