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Durasphere ® EXP

FDA UDI

Class III (US FDA UDI)

by Carbon Medical Technologies, Inc.

Identity

Trade Name
Durasphere ® EXP FDA UDI
Generic Name
Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable FDA UDI
Device Name
Injectable Bulking Agent FDA UDI
Model / Reference
890-215 FDA UDI
Description
Injectable Bulking Agent FDA UDI

Identifiers

Catalog Number
890-215 FDA UDI
Primary DI / UDI-DI
00858015005004 FDA UDI
PMA Number
P980053 FDA UDI
FDA Product Code
LNM FDA UDI
GMDN Term
Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Dimensions & Sizes

Size
Total Volume — 1 Milliliter FDA UDI

Category: Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable

Durasphere ® EXP by Carbon Medical Technologies, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable.

Cleared under the same submission

P980053 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Carbon Medical Technologies, Inc.

Sources (1)

  • FDA UDI ece80d63-45e3-4a00-a618-97e4a651cb00 38 fields · synced Jun 9, 2026