Identity
- Trade Name
- Panni Retractor System FDA UDI
- Generic Name
- Limb/torso/head restraint, single-use FDA UDI
- Model / Reference
- PPR-13 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855459008080 FDA UDI
- FDA Product Code
- HXT FDA UDI
- GMDN Term
- Limb/torso/head restraint, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Category: Limb/torso/head restraint, single-use
Panni Retractor System by Stetrix Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Limb/torso/head restraint, single-use.
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- Bosma Enterprises — Bosma Enterprises · Class I
- MORRISON MEDICAL — MORRISON MEDICAL, LTD · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- Protective Mitt — KENAD SG MEDICAL, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stetrix Inc.
Sources (1)
- FDA UDI f2f7b148-006a-4a58-bb44-0449d7395db1 32 fields · synced Jun 8, 2026