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Tally Surgical Solution

FDA UDI

Class I (US FDA UDI)

by Tally Surgical, Inc.

Identity

Trade Name
Tally Surgical Solution FDA UDI
Generic Name
Radiopaque woven surgical sponge FDA UDI
Device Name
3x3 gauze, 16 ply, banded 10 pack, double X-ray FDA UDI
Model / Reference
10101 FDA UDI
Description
3x3 gauze, 16 ply, banded 10 pack, double X-ray FDA UDI

Identifiers

Catalog Number
10101 FDA UDI
Primary DI / UDI-DI
10810178830005 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radiopaque woven surgical sponge

Tally Surgical Solution by Tally Surgical, Inc. — 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
Tally Surgical, Inc.

Sources (1)

  • FDA UDI 24c6cba3-0f30-4dd9-a3b6-9575b2cf9a97 35 fields · synced May 30, 2026