FDA UDI
In Commercial Distribution
🇺🇸 United States
Integra® Miltex®
DI: 10381780470892
·
Model: ST7-2
·
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- Integra® Miltex®
- Primary DI
- 10381780470892
- Version / Model
- ST7-2
- Catalog Number
- ST7-2
- Company Name
- INTEGRA LIFESCIENCES PRODUCTION CORPORATION
- Labeler DUNS
- 081277700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2018-10-25
- Public Version
- 5
- Public Version Date
- 2023-04-27
- Public Version Status
- Update
- Public Device Record Key
- 7d6bfd01-9ba0-4ab0-a2a7-aaf0be26d20a
Device Description
Integra® Miltex® Halsted Forceps, 4-3/4", Straight, Sterile, Box of 50
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HRQ | HEMOSTAT | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61478 | Surgical soft-tissue manipulation forceps, scissors-like, single-use | A hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues; it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | H834ST721 | HIBCC | ||||
| Primary | 10381780470892 | GS1 | ||||
| Unit of Use | 00381780470895 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do Not use if package is damaged