FDA UDI
In Commercial Distribution
🇺🇸 United States
GORE-TEX Suture
DI: 00733132628797
·
Model: 3U10
·
W. L. Gore & Associates, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- GORE-TEX Suture
- Primary DI
- 00733132628797
- Version / Model
- 3U10
- Catalog Number
- 3U10
- Company Name
- W. L. Gore & Associates, Inc.
- Labeler DUNS
- 967358115
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-13
- Public Version
- 9
- Public Version Date
- 2024-11-11
- Public Version Status
- Update
- Public Device Record Key
- 89ec7e03-251e-4840-b2f5-8bd4dbc81ac8
Device Description
GORE-TEX SUTURE CV-3 122cm DoubleArm PH-24-1dz
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 |
|---|---|---|---|---|
| GAW | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | General, Plastic Surgery | 878.5010 | 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 | 00733132628797 | GS1 | ||||
| Package | 00733132602858 | GS1 | 12 | In Commercial Distribution | ||
| Package | 00733132602865 | GS1 | 36 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)528-8763
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P820083 | 025 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 122 | Centimeter |