FDA UDI
In Commercial Distribution
🇺🇸 United States
Integra® Miltex®
DI: 10381780423584
·
Model: 21-282
·
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Integra® Miltex®
- Primary DI
- 10381780423584
- Version / Model
- 21-282
- Catalog Number
- 21-282
- Company Name
- INTEGRA LIFESCIENCES PRODUCTION CORPORATION
- Labeler DUNS
- 081277700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-10
- Public Version
- 5
- Public Version Date
- 2023-04-28
- Public Version Status
- Update
- Public Device Record Key
- df7c4ad3-1317-49ea-833c-546f5b7af0ce
Device Description
Integra® Miltex® Joseph Nasal Saw 7-1/2", Bayonet Blade, Angled Right, 1-1/2" x 1/4" Blade
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 |
|---|---|---|---|---|
| KBC | SAW, NASAL | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42900 | Nasal saw | A hand-held manual surgical instrument designed for cutting bone and/or cartilage in the nose. It is typically a one-piece metal instrument made of high-grade surgical steel with a handle at the proximal end and a long, thin, serrated blade at the distal end with the cutting teeth set in a straight line, a rounded nose at the tip, and a smooth edge on the top side of the blade to protect tissue not intended to be cut. The instrument is typically used in plastic (i.e., rhinoplasty) and reconstructive procedures of the nose. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | H834212820 | HIBCC | ||||
| Primary | 10381780423584 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 1-1/2" x 1/4" Blade | ||
| Device Size Text, specify | 7-1/2" |