Integra® Miltex®
- Primary DI
- H8342314200
- Brand
- Integra® Miltex®
- Company
- INTEGRA LIFESCIENCES PRODUCTION CORPORATION
- Model
- 23-1420
- Catalog number
- 23-1420
- Device description
- Trousseau Tracheal Dilator, 5-1/2", Standard Size
- Published
- 2018-09-18
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| KCG | DILATOR, TRACHEAL |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KCG | Dilator, Tracheal | Ear, Nose, Throat | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10381780498780 | Primary | GS1 | 0 | |
| H8342314200 | Secondary | HIBCC | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 10381780498780 | 10381780498780 |
GMDN Terms
| Term | Definition |
|---|
| Tracheal surgery dilator, reusable | A hand-held manual surgical instrument intended to be used during surgical intervention of the trachea to dilate tracheal structures/passages, typically during the creation of a tracheostoma and/or for expanding the margins of a tracheostoma to assist in the insertion of a tracheostomy tube. It can be of various designs and sizes, e.g., a slender hollow or solid body made of metal, plastic or other suitable material in a cylindrical form, or a scissors-like instrument that when activated by closing the two ringed-handles, two or three blunted curved prongs expand in opposite directions. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 081277700
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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| 04046826135782 | Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | KCG | 2020-09-24 |
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| 10381780086499 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | KCG | 2018-10-24 |
| 10381780086505 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | KCG | 2018-10-24 |
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