Identity
- Trade Name
- TM "Rehabilitimed" GR-3P L Comfort FDA UDI
- Generic Name
- Pelvic fracture binder, single-use FDA UDI
- Device Name
- It is an inguinal hernia bandage, with a front fastener, graphite color. It is made of elastic fabric and multilayer material (special velor fabric tripled (glued in a special way with polyurethane foam) with cotton terry cloth), equipped with pockets for pads and an additional inguinal belt with fasteners. The bandage is fastened using textile fasteners on the belt. The pads are installed in the pocket of the bandage on one or both sides (depending on the location of the hernia). FDA UDI
- Model / Reference
- GR-3P L Comfort FDA UDI
- Description
- It is an inguinal hernia bandage, with a front fastener, graphite color. It is made of elastic fabric and multilayer material (special velor fabric tripled (glued in a special way with polyurethane foam) with cotton terry cloth), equipped with pockets for pads and an additional inguinal belt with fasteners. The bandage is fastened using textile fasteners on the belt. The pads are installed in the pocket of the bandage on one or both sides (depending on the location of the hernia). FDA UDI
Identifiers
- Catalog Number
- GR-3P L Comfort FDA UDI
- Primary DI / UDI-DI
- 04823097717783 FDA UDI
- FDA Product Code
- IPW FDA UDI
- GMDN Term
- Pelvic fracture binder, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3490 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pelvic fracture binder, single-use
TM "Rehabilitimed" GR-3P L Comfort by Reabilitimed Tov — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pelvic fracture binder, single-use.
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- ARROW — TELEFLEX INCORPORATED · Class I
- Prometheus Pelvic Splint (Tactical) — SAFEGUARD MEDICAL TECHNOLOGIES LIMITED · Class I
- ARROW — TELEFLEX INCORPORATED · Class I
- Pelvic Binder — FARETEC, 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
- Reabilitimed Tov
Sources (1)
- FDA UDI 2546e4b4-f7ae-495a-825e-41499c9cb2ad 36 fields · synced May 30, 2026