Identity
- Trade Name
- Pediatric Headstrap FDA UDI
- Generic Name
- Anaesthesia mask stabilizer, reusable FDA UDI
- Device Name
- The Truer Medical Head Strap features two sleek designs to accommodate adult and child sizes which provide an even distribution of pressure to ensure maximum comfort. With minimal spacing between the holes on the straps, these designs allow for a wide range of locations to secure the straps to any sized individual. FDA UDI
- Model / Reference
- 90518 FDA UDI
- Description
- The Truer Medical Head Strap features two sleek designs to accommodate adult and child sizes which provide an even distribution of pressure to ensure maximum comfort. With minimal spacing between the holes on the straps, these designs allow for a wide range of locations to secure the straps to any sized individual. FDA UDI
Identifiers
- Catalog Number
- 90518 FDA UDI
- Primary DI / UDI-DI
- 00859290006397 FDA UDI
- FDA Product Code
- BTK FDA UDI
- GMDN Term
- Anaesthesia mask stabilizer, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Anaesthesia mask stabilizer, reusable
Pediatric Headstrap by Truer Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia mask stabilizer, reusable.
- Adult Headstrap — TRUER MEDICAL, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Truer Medical, Inc.
Sources (1)
- FDA UDI cccb9abd-c3eb-42db-bff6-0955783c4a50 35 fields · synced Jun 8, 2026