FDA UDI
In Commercial Distribution
🇺🇸 United States
GEMINI Suture Loop
DI: 00842071147297
·
Model: ES4-8000-01
·
APPLIED MEDICAL TECHNOLOGY, INC.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- GEMINI Suture Loop
- Primary DI
- 00842071147297
- Version / Model
- ES4-8000-01
- Catalog Number
- ES4-8000-01, S4-8000-01
- Company Name
- APPLIED MEDICAL TECHNOLOGY, INC.
- Labeler DUNS
- 038101861
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-27
- Public Version
- 1
- Public Version Date
- 2024-12-05
- Public Version Status
- New
- Public Device Record Key
- 1a99e579-26e5-4b6e-9472-2763d3924dec
Device Description
GEMINI Suture Loop with Magnet Technology (Pouched)
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
- Yes
- 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
- 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 |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | 878.5000 | 2 |
| KGC | Tube, Gastro-Enterostomy | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57874 | Suturing unit, single-use | A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00842071147303 | GS1 | Box (S4-8000-01) | 1 | In Commercial Distribution | |
| Primary | 00842071147297 | GS1 |
Customer Contacts
- Phone
- (440)717-4000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241111 | 000 |