Identity
- Trade Name
- Abdominal Binder FDA UDI
- Generic Name
- Abdominal binder, single-use FDA UDI
- Device Name
- Abdominal Binder - Small (30"- 45" / 76-114 cm) FDA UDI
- Model / Reference
- AB201S FDA UDI
- Description
- Abdominal Binder - Small (30"- 45" / 76-114 cm) FDA UDI
Identifiers
- Catalog Number
- AB201S FDA UDI
- Primary DI / UDI-DI
- 00810006681123 FDA UDI
- FDA Product Code
- FSD FDA UDI
- GMDN Term
- Abdominal binder, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5160 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: Abdominal binder, single-use
Abdominal Binder by Primo Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Abdominal binder, single-use.
- DISKARD HEAD HALTER -TRACTION — BIRD & CRONIN, LLC · Class I
- Abdominal Binder 4 Panel — BIRD & CRONIN, LLC · Class I
- MATERNITY MATE LUMBOSACRAL 2XL — BIRD & CRONIN, LLC · Class I
- 12" ABDOMINAL BINDER UP TO 45" — BIRD & CRONIN, LLC · Class I
- 8" ABDOMINAL BINDER 42-48 IN. XL — BIRD & CRONIN, LLC · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Kendall — Cardinalhealth · Class I
- PENDULOUS ABD LUMBO SUPPORT MD — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Primo Inc
Sources (1)
- FDA UDI fcedd609-4a2d-4212-8076-2e982d79cfbc 34 fields · synced May 30, 2026