FDA.report

Tally Surgical Solution

Primary DI
10810178830005
Brand
Tally Surgical Solution
Company
Tally Surgical, Inc.
Model
10101
Catalog number
10101
Device description
3x3 gauze, 16 ply, banded 10 pack, double X-ray
Published
2025-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GDYGauze/Sponge, Internal, X-Ray Detectable

Product Code Classifications

CodeDeviceSpecialtyClass
GDYGauze/Sponge, Internal, X-Ray DetectableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20810178830002PackageGS1128In Commercial Distribution
10810178830005PrimaryGS10
00810178830008Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2081017883000220810178830002
1081017883000510810178830005
00810178830008008101788300088101788300080810178830008

GMDN Terms

TermDefinition
Radiopaque woven surgical spongeA non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
9493848590cgoebig@tallysurgical.com

Regulatory Flags

DUNS number
119447484
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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20810178830026Tally Surgical Solution11101111012025-02-20
20810178830033Tally Surgical Solution11102111022025-02-20
20810178830040Tally Surgical Solution11103111032025-02-20
20810178830057Tally Surgical Solution11104111042025-02-20
20810178830064Tally Surgical Solution11105111052025-02-20
20810178830071Tally Surgical Solution11106111062025-02-20
20810178830088Tally Surgical Solution11107111072025-02-20
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20810178830101Tally Surgical Solution11109111092025-02-20
20810178830118Tally Surgical Solution11110111102025-02-20
20810178830125Tally Surgical Solution11111111112025-02-20
20810178830132Tally Surgical Solution12101121012025-02-20
20810178830149Tally Surgical Solution12102121022025-02-20
20810178830156Tally Surgical Solution12103121032025-02-20
20810178830163Tally Surgical Solution12104121042025-02-20
20810178830170Tally Surgical Solution12105121052025-02-20
20810178830187Tally Surgical Solution12106121062025-02-20
20810178830484Tally Surgical Solution13101131012025-02-20
20810178830491Tally Surgical Solution13102131022025-02-20
20810178830507Tally Surgical Solution13103131032025-02-20

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