FDA.reportPublic FDA data

Tally Surgical Solution

Primary DI
10810178830074
Brand
Tally Surgical Solution
Company
Tally Surgical, Inc.
Model
11106
Catalog number
11106
Device description
12x12 Lap Sponge, banded 5 pack, ring, X-ray detectable
Published
2025-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDYGauze/Sponge, Internal, X-Ray Detectable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDYGauze/Sponge, Internal, X-Ray DetectableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20810178830071PackageGS140In Commercial Distribution
10810178830074PrimaryGS10
00810178830077Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081017883007120810178830071
1081017883007410810178830074
00810178830077008101788300778101788300770810178830077

GMDN Terms#

Term, Definition table
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.

Contacts#

Phone, Email table
PhoneEmail
9493848590cgoebig@tallysurgical.com

Regulatory Flags#

DUNS number
119447484
Device count
5
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810178830029Tally Surgical Solution11101111012025-02-20
10810178830036Tally Surgical Solution11102111022025-02-20
10810178830043Tally Surgical Solution11103111032025-02-20
10810178830050Tally Surgical Solution11104111042025-02-20
10810178830067Tally Surgical Solution11105111052025-02-20
10810178830081Tally Surgical Solution11107111072025-02-20
10810178830098Tally Surgical Solution11108111082025-02-20
10810178830104Tally Surgical Solution11109111092025-02-20
10810178830111Tally Surgical Solution11110111102025-02-20
10810178830128Tally Surgical Solution11111111112025-02-20
10810178830135Tally Surgical Solution12101121012025-02-20
10810178830142Tally Surgical Solution12102121022025-02-20
10810178830159Tally Surgical Solution12103121032025-02-20
10810178830166Tally Surgical Solution12104121042025-02-20
10810178830173Tally Surgical Solution12105121052025-02-20
10810178830180Tally Surgical Solution12106121062025-02-20
10810178830487Tally Surgical Solution13101131012025-02-20
10810178830494Tally Surgical Solution13102131022025-02-20
10810178830500Tally Surgical Solution13103131032025-02-20
10810178830517Tally Surgical Solution13104131042025-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956239692CARDINAL HEALTHCardinal Health 200, LLCGDY2025-11-28
07613327465853SurgiCount Safety-SpongeSTRYKER CORPORATIONGDY2025-09-03
10080196717811MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-04-25
10197106760994CARDINAL HEALTHCardinal Health 200, LLCGDY2025-01-29
10080196031313MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-01-16
10080196743926MEDLINEMEDLINE INDUSTRIES, INC.GDY2024-10-15
10326053119504Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119511Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119528Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119535Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119542Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119559Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119566Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119573Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119580Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
08600036785272USMEDCOUS MEDCO INCGDY2023-07-14
08600036785340USMEDCOUS MEDCO INCGDY2023-07-14
08600036785418USMEDCOUS MEDCO INCGDY2023-07-14
08600036785586USMEDCOUS MEDCO INCGDY2023-07-14
08600036785654USMEDCOUS MEDCO INCGDY2023-07-14
10197106046968CARDINAL HEALTHCardinal Health 200, LLCGDY2023-07-12
10192253050288KerlixCardinal Health 200, LLCGDY2023-03-24
10665973000012DukalDukal LLCGDY2022-12-06
10665973000029DukalDukal LLCGDY2022-12-06
10665973000036DukalDukal LLCGDY2022-12-06
10665973000050DukalDukal LLCGDY2022-12-06
10665973000067DukalDukal LLCGDY2022-12-06
10665973000081DukalDukal LLCGDY2022-12-06
10665973000098DukalDukal LLCGDY2022-12-06
10665973000166DukalDukal LLCGDY2022-12-06