FDA.reportPublic FDA data

Tonsil Sponges

Primary DI
20749915000746
Brand
Tonsil Sponges
Company
AMERICAN SURGICAL COMPANY, LLC
Model
50-00
Device description
"Tonsil Sponges 3/4"" Medium"
Published
2016-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EFQGauze/Sponge, Internal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFQGauze/Sponge, InternalUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K872806000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K872806000STICK SPONGE, STRUNG TONSIL SPONGE DOUBLE STRUNGAmerican Silk Sutures, Inc.1987-08-04EFQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20749915000746PrimaryGS10
10749915000749Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2074991500074620749915000746
1074991500074910749915000749

GMDN Terms#

Term, Definition table
TermDefinition
Dissection spongeA sterile device intended to be used for blunt tissue dissection during a surgical procedure (e.g., from gross dissection to delicate neurological surgery). It typically consists of a small sponge made of hard but absorbent material (e.g., cotton twill, gauze, rayon) and frequently including an x-ray radiopaque element; some types include a hole in the centre to facilitate manipulation with forceps. It is available in a wide range of sizes and shapes (e.g., rosebud, peanut, cherry, round, Kittner). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
151054954
Device count
40
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749915002937Atlas Choice Microsurgery Pattie Collection301-012021-12-09
00749915002944Atlas Choice Cranial Pattie Collection300-012021-12-09
00749915002852Tapered Delicot63-08T2021-08-26
00749915002876Tapered Delicot63-13T2021-08-26
00749915002890Tapered Delicot63-14T2021-08-26
00749915002913Tapered Delicot63-15T2021-08-26
10749915002842Tapered Delicot63-08T2021-08-26
10749915002866Tapered Delicot63-13T2021-08-26
10749915002880Tapered Delicot63-14T2021-08-26
10749915002903Tapered Delicot63-15T2021-08-26
20749915002665Tapered Delicot63-05T2021-06-01
00749915002753Tapered Delicot63-06T2021-06-01
00749915002777Tapered Delicot63-07T2021-06-01
00749915002791Tapered Delicot63-09T2021-06-01
00749915002807Tapered Delicot63-11T2021-06-01
00749915002838Tapered Delicot63-12T2021-06-01
20749915002733Tapered Delicot63-06T2021-06-01
10749915002767Tapered Delicot63-07T2021-06-01
10749915002781Tapered Delicot63-09T2021-06-01
10749915002811Tapered Delicot63-11T2021-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253047509CurityCardinal Health 200, LLCEFQ2026-04-08
50192253067888ASOCardinal Health 200, LLCEFQ2026-01-20
B960RED202RED Prep-KitNeuraxis, Inc.EFQ2025-01-09
00630094194110Bioseal Inc.BIOSEALEFQ2023-10-11
10192253047523CurityCardinal Health 200, LLCEFQ2023-10-09
10192253047561CurityCardinal Health 200, LLCEFQ2023-10-09
00665973017228DukalDukal LLCEFQ2022-12-06
00665973017235DukalDukal LLCEFQ2022-12-06
00665973017242DukalDukal LLCEFQ2022-12-06
00683534830017A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830024A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830031A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830048A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830055A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830062A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830079A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830086A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830093A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830109A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830116A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830123A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830130A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830147A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830154A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830161A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830178A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830185A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830277A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830284A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830307A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19