Identity
- Trade Name
- Rocket FDA UDI
- Generic Name
- Rectal medication applicator, single-use FDA UDI
- Device Name
- Rocket Rectal Solution Set FDA UDI
- Model / Reference
- R56215-M FDA UDI
- Description
- Rocket Rectal Solution Set FDA UDI
Identifiers
- Catalog Number
- R56215-M FDA UDI
- Primary DI / UDI-DI
- 05055270979308 FDA UDI
- FDA Product Code
- FCE FDA UDI
- GMDN Term
- Rectal medication applicator, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5210 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: Rectal medication applicator, single-use
Rocket by Rocket Medical Plc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rectal medication applicator, single-use.
- Sephure® suppository applicator — Cristcot LLC · Class I
- Sephure® suppository applicator — Cristcot LLC · Class I
- Sephure® suppository applicator — Cristcot LLC · Class I
- Synalax — Cristcot LLC · Class I
- Sephure® suppository applicator — Cristcot LLC · Class I
- Sephure® suppository applicator — Cristcot LLC · Class I
- Proctowash — INTERMARK MEDICAL INNOVATIONS LIMITED · Class I
- Sephure® suppository applicator — Cristcot 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Rocket Medical Plc
Sources (1)
- FDA UDI 581b91b5-152a-412a-a40a-88347005e3eb 34 fields · synced May 30, 2026