FDA UDI
In Commercial Distribution
🇺🇸 United States
ROLLER FOAM FULL ROLL 36" LONG X 6" WIDE ALIMED 3/CS
DI: 00733657290684
·
Model: 3171603
·
ALIMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
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Basic Information
- Brand Name
- ROLLER FOAM FULL ROLL 36" LONG X 6" WIDE ALIMED 3/CS
- Primary DI
- 00733657290684
- Version / Model
- 3171603
- Company Name
- ALIMED, INC.
- Labeler DUNS
- 056007248
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2022-12-01
- Public Version
- 3
- Public Version Date
- 2024-02-26
- Public Version Status
- Update
- Public Device Record Key
- b9c53d23-0458-4730-b243-a7049bdc1172
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ION | EXERCISER, NON-MEASURING | Physical Medicine | 890.5370 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66493 | Pilates reformer exerciser | A non-powered, whole-body exercise apparatus intended primarily to strengthen and improve flexibility of the core, lower body, and upper body muscle groups, and to improve posture and range of motion, through repetitive movements against spring resistance. It consists of a floor-standing frame with a sliding sled/platform upon which the user stands, sits, kneels or lies, and adjustable ropes, loops/handles, rollers, anchoring bars, and springs of various resistances. This device is designed for therapeutic programs in physiotherapy, rehabilitation, sports therapy, prevention, functional fitness, and recreational sports. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00733657290684 | GS1 | ||||
| Unit of Use | 00733657298987 | GS1 |
Customer Contacts
- Phone
- +1(781)329-2900 ext. 0
- [email protected]