FDA UDI
In Commercial Distribution
🇺🇸 United States
USA Umbilical Cord Scissors
DI: G25002055100
·
Model: 02-055-10
·
N S SURGICAL COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- USA Umbilical Cord Scissors
- Primary DI
- G25002055100
- Version / Model
- 02-055-10
- Catalog Number
- 02-055-10
- Company Name
- N S SURGICAL COMPANY
- Labeler DUNS
- 645681649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-18
- Public Version
- 1
- Public Version Date
- 2023-03-27
- Public Version Status
- New
- Public Device Record Key
- 40ba43fc-1b29-463f-9322-67ec7691f2e7
Device Description
A hand-held manual surgical instrument designed specifically to cut the umbilical cord after birth. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is metallic and is available in various designs and sizes; the blades can have a variety of sizes and designs, e.g., curved, acutely angled at the tip, or have flat opposing moon shapes, and may be serrated. This is a reusable device.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ultraviolet Light, Moist Heat or Steam Sterilization, Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HDJ | Scissors, Umbilical | Obstetrics/Gynecology | 884.4520 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32602 | Umbilical cord scissors, reusable | A hand-held manual surgical instrument designed specifically to cut the umbilical cord after birth. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is metallic and is available in various designs and sizes; the blades can have a variety of sizes and designs, e.g., curved, acutely angled at the tip, or have flat opposing moon shapes, and may be serrated. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G25002055100 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 10.5 | Centimeter |