FDA UDI
In Commercial Distribution
🇺🇸 United States
Integra® Miltex®
DI: 10381780159940
·
Model: 26591
·
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
12
Basic Information
- Brand Name
- Integra® Miltex®
- Primary DI
- 10381780159940
- Version / Model
- 26591
- Catalog Number
- 26-591
- Company Name
- INTEGRA LIFESCIENCES PRODUCTION CORPORATION
- Labeler DUNS
- 081277700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2016-08-03
- Public Version
- 6
- Public Version Date
- 2023-04-28
- Public Version Status
- Update
- Public Device Record Key
- 293f1151-e7ef-420b-80df-02e679bd2e14
Device Description
Integra® Miltex® Raney Reusable Scalp Clips - (12/pack)
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
- No
- 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 |
|---|---|---|---|---|
| HBO | CLIP, SCALP | Neurology | 882.4150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34959 | Scalp haemostasis clip, reusable | A small, manually-operated and applied surgical device used to stop bleeding from the scalp during surgery on the cranium. It is is usually applied to the scalp using the fingers or a dedicated pair of scalp clip forceps, and consists of two blades that are joined at a midpoint or is made of a single alpha-shaped part. It is typically made of high-grade stainless steel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | H834265911 | HIBCC | ||||
| Primary | 10381780159940 | GS1 | ||||
| Unit of Use | 00381780159943 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K033660 | 000 |