FDA UDI
In Commercial Distribution
🇺🇸 United States
RoG Rope
DI: 00855152006031
·
Model: 10-1341
·
Rog Sports Medicine, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- RoG Rope
- Primary DI
- 00855152006031
- Version / Model
- 10-1341
- Company Name
- Rog Sports Medicine, Inc.
- Labeler DUNS
- 006254430
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-13
- Public Version
- 4
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 37c8dd3e-e570-498a-8408-9a5194d230c3
Device Description
UHMWPE #2 Suture
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
- 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 |
|---|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13907 | Polyolefin/fluoropolymer suture, multifilament | A multiple-strand (multifilament), 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 |
|---|---|---|---|---|---|---|
| Package | 10855152006038 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00855152006031 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113299 | 000 |