Identity
- Trade Name
- PIN STRAPS - CINTURE IMMOBILIZZ. SPINALE ADULTO EUDAMEDSpencer FDA UDI
- Generic Name
- Limb/torso/head restraint, reusable FDA UDI
- Model / Reference
- Restraint Belts EUDAMEDST02015 EUDAMEDST02015A PIN STRAPS - SISTEMA DI CINTURE CON GANCI FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08057711230945 EUDAMEDFDA UDI
- Basic UDI-DI
- 805771123CINTUREIMMOBAK EUDAMED
- Direct Marketing DI
- 08057711230945 EUDAMED
- FDA Product Code
- NZD FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Limb/torso/head restraint, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6900 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Limb/torso/head restraint, reusable
Spencer by Spencer Italia Srl — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Limb/torso/head restraint, reusable.
- E.M Adams co, inc. — E.M. Adams · Class I
- E.M. Adams Co, Inc. — E.M. Adams · Class I
- E.M. ADAMS CO, INC — E.M. Adams · Class I
- POSEY — POSEY PRODUCTS, LLC · Class I
- Morrison Medical — MORRISON MEDICAL, LTD · Class I
- Restraint strap — Skytron, LLC · Class I
- E.M Adams co, inc. — E.M. Adams · Class I
- MORRISON MEDICAL — MORRISON MEDICAL, LTD · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Spencer Italia Srl
Sources (2)
- FDA UDI cad91499-3fa8-4e3c-8698-20f26a4349fa 32 fields · synced Oct 9, 2026
- EUDAMED 76a5829b-d519-4c7b-8c6e-acab3871f65d 61 fields · synced Oct 9, 2026