FDA UDI
In Commercial Distribution
🇺🇸 United States
MD™ QUICK LOAD®
DI: 00850012846246
·
Model: 023160
·
LSI Solutions, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MD™ QUICK LOAD®
- Primary DI
- 00850012846246
- Version / Model
- 023160
- Catalog Number
- 023160
- Company Name
- LSI Solutions, Inc.
- Labeler DUNS
- 603420183
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-22
- Public Version
- 1
- Public Version Date
- 2022-12-30
- Public Version Status
- New
- Public Device Record Key
- 136e9982-7aab-406b-9c8e-b1e3a17d7d32
Device Description
MD™ QUICK LOAD® SUTURE (2-0 Polyester, Green, Non-absorbable, 38") with Needle Cap Unloader
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| GAS | Suture, nonabsorbable, synthetic, polyester | General, Plastic Surgery | 878.5000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13906 | Polyester suture, non-bioabsorbable, multifilament | A multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester 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 |
|---|---|---|---|---|---|---|
| Package | 10850012846243 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 00850012846246 | GS1 |
Customer Contacts
- Phone
- +1(866)575-3493
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203081 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 38 | Inch |