FDA.reportPublic FDA data

Tally Surgical Solution

Primary DI
20810178830484
Brand
Tally Surgical Solution
Company
Tally Surgical, Inc.
Model
13101
Catalog number
13101
Device description
2x36 LD Sponge, 4 ply, 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
Rx
false
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
20810178830484PackageGS1100In Commercial Distribution
10810178830487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081017883048420810178830484
1081017883048710810178830487

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9493848590cgoebig@tallysurgical.com

Regulatory Flags#

DUNS number
119447484
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
20810178830095Tally Surgical Solution11108111082025-02-20
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
20810178830491Tally Surgical Solution13102131022025-02-20
20810178830507Tally Surgical Solution13103131032025-02-20
20810178830514Tally Surgical Solution13104131042025-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50192253050293VistecCardinal Health 200, LLCGDY2026-03-05
10815555025678CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025685CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025661CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025630CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025623CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025647CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025654CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
50198956239690CARDINAL HEALTHCardinal Health 200, LLCGDY2025-11-28
10850049994863Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994870Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994887Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994894Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994900Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994917Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994924Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994931Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994948Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994955Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994962Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994979SynterventionZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994993Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-23
10850049994986Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-22
37613327465854SurgiCount Safety-SpongeSTRYKER CORPORATIONGDY2025-09-03
06979032640079GOBENHUZHOU JUNDA INDUSTRY CO., LTD.GDY2025-08-26
30193489015991MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-06-12
40888277338914MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-06-06
40193489079747MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-06-06
40193489079754MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-06-06
40193489079822MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-06-06