← Back to catalogue

Elbow Sleeve Neoprene

FDA UDI

Class I (US FDA UDI)

by AliMed, LLC

Identity

Trade Name
ELBOW SLEEVE NEOPRENE FDA UDI
Generic Name
Disease-associated prion protein (PrPSc) IVD, kit, enzyme immunohistochemistry FDA UDI
Model / Reference
52337/NA/NA/SM FDA UDI

Identifiers

Catalog Number
2970002650 FDA UDI
Primary DI / UDI-DI
00733657233773 FDA UDI
FDA Product Code
IOY FDA UDI
GMDN Term
Disease-associated prion protein (PrPSc) IVD, kit, enzyme immunohistochemistry FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3475 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Disease-associated prion protein (PrPSc) IVD, kit, enzyme immunohistochemistry

Elbow Sleeve Neoprene by AliMed, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Disease-associated prion protein (PrPSc) IVD, kit, enzyme immunohistochemistry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
AliMed, LLC

Sources (1)

  • FDA UDI 9c487335-2b2d-42f1-afcd-6fa5684219a8 34 fields · synced Jun 9, 2026