FDA UDI
In Commercial Distribution
🇺🇸 United States
LUER RETRACTOR
DI: 00192896089624
·
Model: 502-405
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LUER RETRACTOR
- Primary DI
- 00192896089624
- Version / Model
- 502-405
- Catalog Number
- 502-405
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-24
- Public Version
- 1
- Public Version Date
- 2018-11-26
- Public Version Status
- New
- Public Device Record Key
- 5fecf37f-03e8-4bbc-9375-863905697219
Device Description
LUER RETRACTOR DOUBLE ENDED S-SHAPED TIPS
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", "Dry Heat Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KAL | RETRACTOR, ENT | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35112 | Tracheal hook | A double-ended surgical instrument designed to hold the trachea steady during the creation of a tracheostoma and/or for separating/drawing aside the margins of a tracheostoma to assist in the insertion of a tracheostomy tube. It can be of various designs, e.g., double or single-ended with one end forming a broad bladed retractor and the opposite end tapers to form a pointed hook formed at various angles or multiple parallel hooks. It is made of high-grade stainless steel. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00192896089624 | GS1 |
Customer Contacts
- Phone
- +1(800) 821-7496
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 10 X 5 Millimeter Tip | ||
| Device Size Text, specify | 14 x 9 Millimeter Tip | ||
| Length | 5.5 | Inch |