FDA UDI
In Commercial Distribution
🇺🇸 United States
HORSESHOE Head Strap
DI: 00860013007669
·
Model: HSTRAP
·
Surgicure Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HORSESHOE Head Strap
- Primary DI
- 00860013007669
- Version / Model
- HSTRAP
- Catalog Number
- HSTRAP
- Company Name
- Surgicure Technologies, Inc.
- Labeler DUNS
- 117605066
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-04
- Public Version
- 1
- Public Version Date
- 2026-03-12
- Public Version Status
- New
- Public Device Record Key
- aead712a-edee-4c30-8324-d1fa94e3dbe6
Device Description
Endotracheal Tube Securement Device Head Strap
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
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CBH | Device, Fixation, Tracheal Tube | Anesthesiology | 868.5770 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35815 | Endotracheal tube holder | A device designed to hold and stabilize an endotracheal (ET) tube when it has been intubated into a patient; it may also include a teeth protector to prevent damage to the teeth or tube during intubation. It typically consists of straps, pinch rings, cloth ties, or Velcro bands and provides the advantage of easy readjustment of the tube without retaping or the use of safety pins. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00860013007676 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00860013007669 | GS1 |
Customer Contacts
- Phone
- 5084434839
- [email protected]