FDA UDI
In Commercial Distribution
🇺🇸 United States
Integra® Jarit®
DI: 10381780201700
·
Model: 475472
·
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Integra® Jarit®
- Primary DI
- 10381780201700
- Version / Model
- 475472
- Catalog Number
- 475-472
- Company Name
- INTEGRA LIFESCIENCES PRODUCTION CORPORATION
- Labeler DUNS
- 081277700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-16
- Public Version
- 5
- Public Version Date
- 2023-04-24
- Public Version Status
- Update
- Public Device Record Key
- 016d1f30-b8f3-4229-ab10-b2aad449f016
Device Description
Integra® Jarit® Randall Kidney Stone Forceps, 7-3/4", Three Quarter Curve
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEN | FORCEPS, GENERAL & PLASTIC SURGERY | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35083 | Open-surgery stone-retrieval forceps | A hand-held manual surgical instrument designed to grasp and/or manipulate a calculus (i.e., a kidney or gallbladder stone) during an open surgical procedure; additional intended uses may include soft-tissue manipulation (e.g., polyp removal). It is typically made of high-grade stainless steel and is of scissors-like design with two handles attached to two long curved blades. The handles may be permanently joined or conjoined, usually by pressure, during use. The distal gripping blades may be designed with serrated and/or ringed or slotted grasping surfaces. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | M2744754721 | HIBCC | ||||
| Primary | 10381780201700 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]