Identity
- Trade Name
- Richard-Allan® DISPOS-A-PAK FDA UDI
- Generic Name
- Suturing needle, single-use FDA UDI
- Device Name
- Intent to be used with suture material for tissue closure FDA UDI
- Model / Reference
- 512 FDA UDI
- Description
- Intent to be used with suture material for tissue closure FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840113206346 FDA UDI
- FDA Product Code
- GAB FDA UDI
- GMDN Term
- Suturing needle, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Suturing needle, single-use
Richard-Allan® DISPOS-A-PAK by Aspen Surgical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Aspen Surgical Products, Inc.
Sources (1)
- FDA UDI 716bff73-ec40-4400-9813-bee9c708c681 34 fields · synced Jun 9, 2026