FDA UDI
In Commercial Distribution
🇺🇸 United States
Perchik Button™
DI: 10884450786199
·
Model: A
·
Merit Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Perchik Button™
- Primary DI
- 10884450786199
- Version / Model
- A
- Catalog Number
- H787138002015
- Company Name
- Merit Medical Systems, Inc.
- Labeler DUNS
- 184763290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-07-02
- Public Version
- 1
- Public Version Date
- 2024-07-10
- Public Version Status
- New
- Public Device Record Key
- 1b7e9b46-d0c6-46ef-a1eb-d6d4e726f1bc
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| KGS | RETENTION DEVICE, SUTURE | General, Plastic Surgery | 878.4930 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33519 | Suture retention device | A device designed to be placed on the surface of the skin and intended to aid wound healing by distributing suture tension over a larger area in the patient. It is typically in the form of a retention bridge, a surgical button, or a suture bolster through which the sutures are passed. The distribution of suture tension will help prevent the suture from cutting the skin. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00884450786192 | GS1 | ||||
| Primary | 10884450786199 | GS1 |