FDA UDI
In Commercial Distribution
🇺🇸 United States
UNIMDE B
DI: 16285379148909
·
Model: DW5723
·
UNITED MEDICAL INDUSTRIES CO. LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- UNIMDE B
- Primary DI
- 16285379148909
- Version / Model
- DW5723
- Catalog Number
- DW5723
- 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
- 74540d09-6c62-437e-800f-53038fc25ba7
Device Description
Braided, Polyamide, Synthetic, 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 |
|---|---|---|---|---|
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | General, Plastic Surgery | 878.5020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37997 | Nylon suture, non-bioabsorbable, multifilament | A multiple-strand (multifilament), 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 to withstand normal stress. 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 06285379148902 | GS1 | ||||
| Primary | 16285379148909 | GS1 |
Customer Contacts
- Phone
- +966112650665
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042284 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 0.4 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius