FDA UDI
In Commercial Distribution
🇺🇸 United States
PDT, Inc.
DI: 00813677023452
·
Model: T801 Iris Curved Black Scissors (11.5cm)
·
PDT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PDT, Inc.
- Primary DI
- 00813677023452
- Version / Model
- T801 Iris Curved Black Scissors (11.5cm)
- Catalog Number
- T801
- Company Name
- PDT, INC.
- Labeler DUNS
- 125850144
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-01
- Public Version
- 2
- Public Version Date
- 2025-08-05
- Public Version Status
- Update
- Public Device Record Key
- 43b84be2-5abf-4bc8-af40-c0fb38e3e17f
Device Description
The PDT Iris Curved Black Scissors (11.5cm) are designed for trimming tissue or snipping sutures. These black scissors do not reflect light, and are coated for increased strength and edge durability with 85 Rockwell C hardness.
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
- Moist Heat or Steam Sterilization, Dry Heat Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EGN | Scissors, Surgical Tissue, Dental | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31822 | Dental surgical scissors | A hand-held dental instrument used to cut oral tissue during a dental surgical procedure. 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 typically made of high-grade stainless steel and has blades that terminate in sharp, fine, points. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00813677023452 | GS1 |