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Situate

FDA UDI

Class I (US FDA UDI)

by Covidien LP

Identity

Trade Name
Situate FDA UDI
Generic Name
Radiopaque woven surgical sponge FDA UDI
Device Name
Gauze - RF and X-ray Detectable USP Type VII, 32 Ply FDA UDI
Model / Reference
G0804-32P02C-1 FDA UDI
Description
Gauze - RF and X-ray Detectable USP Type VII, 32 Ply FDA UDI

Identifiers

Primary DI / UDI-DI
10884521700895 FDA UDI
FDA Product Code
GDY FDA UDI
GMDN Term
Radiopaque woven surgical sponge FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4450 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

Yes

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
Length — 4 Inch FDA UDI
Width — 8 Inch FDA UDI

Category: Radiopaque woven surgical sponge

Situate by Covidien LP — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiopaque woven surgical sponge.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Covidien LP

Sources (1)

  • FDA UDI 6052a114-77e5-4217-b584-b73f467cf62b 36 fields · synced Jun 6, 2026