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Ranawat / Burstein Hip System

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name
RANAWAT / BURSTEIN HIP SYSTEM FDA UDI
Generic Name
Ureteral catheter holder FDA UDI
Model / Reference
105846 FDA UDI

Identifiers

Catalog Number
105846 FDA UDI
Primary DI / UDI-DI
00880304193079 FDA UDI
510(k) Number
K921277 FDA UDI
FDA Product Code
LPH FDA UDI
GMDN Term
Ureteral catheter holder FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3358 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

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Ureteral catheter holder

Ranawat / Burstein Hip System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ureteral catheter holder.

Cleared under the same submission

K921277 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomet Orthopedics, Inc.

Sources (1)

  • FDA UDI bbeacb5b-2d39-48f3-8ed0-15c7f8375bd7 36 fields · synced May 30, 2026