Identity
- Trade Name
- SIERRA ROMER W/OVERDOOR STRAP FDA UDI
- Generic Name
- Upper-limb mechanical weight exerciser, lever/pulley-cable FDA UDI
- Model / Reference
- 08143640 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00610570063666 FDA UDI
- FDA Product Code
- IOD FDA UDI
- GMDN Term
- Upper-limb mechanical weight exerciser, lever/pulley-cable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5350 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Upper-limb mechanical weight exerciser, lever/pulley-cable
Sierra Romer W/Overdoor Strap by Bird & Cronin, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Upper-limb mechanical weight exerciser, lever/pulley-cable.
- SilverStar, Wall Mounted Overhead Pulley — HAUSMANN ENTERPRISES, LLC · Class I
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- EN-Dynamic Triceps Dips — Enraf-Nonius B.V. · Class I
- EN-Dynamic Shoulder Press — Enraf-Nonius B.V. · Class I
- PERFORMANCE HEALTH — Asp Global, LLC · Class I
- PERFORMANCE HEALTH — Asp Global, LLC · Class I
- RANIER ROMER W/OVERDOOR STRAP — BIRD & CRONIN, LLC · Class I
- THERATEK SIERRA ROMER W/STRAP — BIRD & CRONIN, LLC · 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
- Bird & Cronin, Llc
Sources (1)
- FDA UDI e613cbf7-0091-427c-8098-a74fabfa01f5 32 fields · synced Jun 8, 2026