FDA UDI
In Commercial Distribution
🇺🇸 United States
Professional Surgical Instruments Co., Inc.
DI: 00853863007804
·
Model: OMS2629-5C
·
Professional Surgical Instruments Co., Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Professional Surgical Instruments Co., Inc.
- Primary DI
- 00853863007804
- Version / Model
- OMS2629-5C
- Company Name
- Professional Surgical Instruments Co., Inc.
- Labeler DUNS
- 197354343
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-15
- Public Version
- 1
- Public Version Date
- 2025-05-23
- Public Version Status
- New
- Public Device Record Key
- 021f4261-38e3-489a-b2ce-50747c1263f7
Device Description
5" 1x2 Tissue Forceps Insert, Wire Form
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HTD | Forceps | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62479 | Surgical soft-tissue manipulation forceps, tweezers-like, single-use | A hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10853863007801 | GS1 | 300 | In Commercial Distribution | ||
| Primary | 00853863007804 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 5 | Inch |