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Percuvance

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
PERCUVANCE FDA UDI
Generic Name
Laparoscopic access cannula seal reducer, single-use FDA UDI
Device Name
12 MM SEAL BRIDGE FDA UDI
Model / Reference
IPN027877 FDA UDI
Description
12 MM SEAL BRIDGE FDA UDI

Identifiers

Catalog Number
PCVSB12 FDA UDI
Primary DI / UDI-DI
14026704582881 FDA UDI
510(k) Number
K153063 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Laparoscopic access cannula seal reducer, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 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

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 3.4 Inch FDA UDI
Width — 0.7 Inch FDA UDI

Category: Laparoscopic access cannula seal reducer, single-use

Percuvance by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laparoscopic access cannula seal reducer, single-use.

Cleared under the same submission

K153063 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (1)

  • FDA UDI 9836a19f-302b-4e9f-9b05-49eb0f8494e3 38 fields · synced Jun 1, 2026