FDA.reportPublic FDA data

Tally Surgical Solution

Primary DI
10810178830005
Brand
Tally Surgical Solution
Company
Tally Surgical, Inc.
Model
10101
Catalog number
10126
Device description
3x3 gauze, 16 ply, banded 10 pack, double X-ray
Published
2025-02-18
Public version status
Update
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
20810178830002PackageGS1128In Commercial Distribution
10810178830005PrimaryGS10
00810178830008Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081017883000220810178830002
1081017883000510810178830005
00810178830008008101788300088101788300080810178830008

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
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#

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
10810178830074Tally Surgical Solution11106111062025-02-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536924000BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
00199536924024BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
00199536924031BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
00199536924055BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
10198956239692CARDINAL HEALTHCardinal Health 200, LLCGDY2025-11-28
20192253046141VistecCardinal Health 200, LLCGDY2025-11-06
00850049994866SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994873SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994880SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994897SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994903SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994910SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994927SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994934SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994941SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994958SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994965SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994972SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994996SynterventionZien Medical Technologies, LLCGDY2025-09-23
00850049994989SynterventionZien Medical Technologies, LLCGDY2025-09-22
07613327465853SurgiCount Safety-SpongeSTRYKER CORPORATIONGDY2025-09-03
10080196717811MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-04-25
20192253047223VistecCardinal Health 200, LLCGDY2025-02-07
10197106760994CARDINAL HEALTHCardinal Health 200, LLCGDY2025-01-29
10080196031313MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-01-16
10080196743926MEDLINEMEDLINE INDUSTRIES, INC.GDY2024-10-15
20192253047285VistecCardinal Health 200, LLCGDY2024-04-15
20192253047308VistecCardinal Health 200, LLCGDY2024-03-15
10326053119504Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119511Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09