FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SharpShooter® Surgical Suture
DI: M928HS47041
·
Model: HS4704
·
IVY SPORTS MEDICINE LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- SharpShooter® Surgical Suture
- Primary DI
- M928HS47041
- Version / Model
- HS4704
- Catalog Number
- HS4704
- Company Name
- IVY SPORTS MEDICINE LLC
- Labeler DUNS
- 046226406
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 7
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 7431628a-1b2e-4405-8a47-f1f163a322f2
- Distribution End Date
- 2018-06-30
Device Description
UHMWPE Suture for SharpShooter®
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
- Yes
- 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 |
|---|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | 878.5000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13909 | Polyolefin/fluoropolymer suture, monofilament | A single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) 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 |
|---|---|---|---|---|---|---|
| Primary | M928HS47041 | HIBCC | ||||
| Package | M928HS47042 | HIBCC | Carton | 10 | Not in Commercial Distribution | 2018-06-30 |
Customer Contacts
- Phone
- 1-800-624-4422
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | USP 2-0 (except for diameter) |