FDA UDI
In Commercial Distribution
🇺🇸 United States
SuperClip Securement Clasp
DI: 10815614020583
·
Model: 4600-10
·
SEMLER TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- SuperClip Securement Clasp
- Primary DI
- 10815614020583
- Version / Model
- 4600-10
- Catalog Number
- 140-0600-10
- Company Name
- SEMLER TECHNOLOGIES, INC.
- Labeler DUNS
- 042075700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-30
- Public Version
- 4
- Public Version Date
- 2023-07-04
- Public Version Status
- Update
- Public Device Record Key
- 4861c288-e97b-4f89-980b-751d28c3c7d2
Device Description
The SuperClip is a sterile, single-use clip that can be used to secure drapes, guidewires or catheters during a vascular access or other cannulation procedure. Ridges on the ergonomically curved handle enables secure manipulation, and elastomeric pads provide a secure grip on drapes, wires, and catheters. The Model 4600-10 is pink in color.
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
- Yes
- 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 |
|---|---|---|---|---|
| KGZ | Accessories, Catheter | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66742 | Surgical drape clip, single-use | A device designed to be used to transiently hold sections of drape together or to a medical device/equipment during a surgical procedure. It is typically in the form of a curved blade or two joined blades. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10815614020583 | GS1 | ||||
| Package | 20815614020580 | GS1 | Box | 10 | In Commercial Distribution | |
| Package | 30815614020587 | GS1 | Case | 12 | In Commercial Distribution |