Is this your brand? Sign in to claim ownership.
Sign in to claim this brandCUSTOM ASSEMBLIES, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 330 EAST MAIN STREET, PINE LEVEL, NC, 27568
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3000718854
- DUNS Number
- —
Catalogue (336)
Page 7 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Custom Medical Specialties, Inc. | CMS-6039 | FDA UDI | Class II | Active |
| Mpm | MPM-320 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-2450-R4 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-3636-BB | FDA UDI | Class II | Active |
| Robbins Instruments | 9.1999 | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-905P | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-820 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-1105-NS | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-2496-R2 | FDA UDI | Class II | Active |
| Robbins Instruments | 9.1906 | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-4140-R4 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-4615 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-4627 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-6056 | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-8963-R1 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-203 | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-0424-PC-GEL | FDA UDI | Class II | Active |
| Mpm | MPM-295 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-6970-R2 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-4655 | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-6977-R1 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-4331-R7B | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-5234-R1 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-1814 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-4439-R5 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-955P-8 | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-2009-R6 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-4477-R4 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-4536-R1 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-4559-R2 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-6998-R1 | FDA UDI | Class II | Active |
| Mpm | MPM-318 | FDA UDI | Class II | Active |
| Mpm | MPM-332 | FDA UDI | Class II | Active |
| Mpm | MPM-536-R1 | FDA UDI | Class II | Active |
| Mpm | MPM-350-B | FDA UDI | Class II | Active |
| Intravascular Administration Set | K993463 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 15, 2017 | Z-3059-2017 | — | terminated | The firm manufactured and distributed custom surgical kits which contained BD SafetyGlide" 22GA 1 inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection. |