FDA.report

Tally Surgical Solution

Primary DI
20810178830132
Brand
Tally Surgical Solution
Company
Tally Surgical, Inc.
Model
12101
Catalog number
12101
Device description
OR Towel, banded 2 pack, Blue, 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

Related Records

Product Codes

CodeName
FRLFiber, Medical, Absorbent

Product Code Classifications

CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20810178830132PackageGS140In Commercial Distribution
10810178830135PrimaryGS10
00810178830138Unit of UseGS10

GMDN Terms

TermDefinition
Dry medical towel/wipe, single-useA dry fabric intended to be used to wipe or dry a patient’s intact skin (not related to wound care), clean medical devices/equipment (e.g., endoscopes, ultrasound systems), and/or clean the general environment (e.g., fluid spill). It may be moistened (e.g., with water or used together with disinfectant/cleaning solutions) however no solutions are included. Some devices may be provided sterile, or designed to be sterilized, for use under sterile conditions [e.g., within an operating room (OR)]; devices intended for non-surgical applications may be provided and used in a non-sterile state. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
9493848590cgoebig@tallysurgical.com

Regulatory Flags

DUNS number
119447484
Device count
2
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 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
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
20810178830514Tally Surgical Solution13104131042025-02-20

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26931918102051HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
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26931918107933HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
10858303003009Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.FRL2025-09-25
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10858303003047Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.FRL2025-09-25
26931918100910HALYARDGRI Medical & Electronic Technology Co., Ltd.FRL2025-09-17
26931918146857AllesetGRI Medical & Electronic Technology Co., Ltd.FRL2025-06-20
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20810178830156Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
20810178830163Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
20810178830170Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
20810178830187Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
E2212248Sticky TimVOCO GmbHFRL2025-01-22
00653160382921MEDLINEMEDLINE INDUSTRIES, INC.FRL2025-01-15