FDA.reportPublic FDA data

Cylindrical Sponge

Primary DI
20749915001651
Brand
Cylindrical Sponge
Company
AMERICAN SURGICAL COMPANY, LLC
Model
70-01
Device description
"Cylindrical Sponges-Strung 3/8"" x 1.5"""
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
EFNCotton, Roll

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFNCotton, RollDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K872810000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K872810000STRUNG DENTAL ROLLSAmerican Silk Sutures, Inc.1987-12-04EFN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20749915001651PrimaryGS10
10749915001654Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2074991500165120749915001651
1074991500165410749915001654

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
50
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
00810194401657AiraAIRA, LLCEFN2026-01-16
00810194401794AiraAIRA, LLCEFN2026-01-16
00810124536909Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyEFN2025-12-05
50732224001086Ultra Gauze Non-Woven SpongesCROSSTEX INTERNATIONAL, INC.EFN2025-10-23
00810124531843Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyEFN2025-09-03
00810132808203House Brand DentistryFrontier Dental Supply IncEFN2025-08-05
10810132808200House Brand DentistryFrontier Dental Supply IncEFN2025-08-05
00840456214947JMUJMU DENTAL, INCEFN2025-07-15
00840456214954JMUJMU DENTAL, INCEFN2025-07-15
00840456214961JMUJMU DENTAL, INCEFN2025-07-15
00840456214978JMUJMU DENTAL, INCEFN2025-07-15
00810132044281HCS SourcingConcordance Healthcare Solutions LLCEFN2025-04-07
20810132044285HCS SourcingConcordance Healthcare Solutions LLCEFN2025-04-07
00810132044274HCSConcordance Healthcare Solutions LLCEFN2025-03-05
20810132044278HCSConcordance Healthcare Solutions LLCEFN2025-03-05
D77810701991Scott's Select Cotton RollsSCOTT'S DENTAL SUPPLY L.L.C.EFN2024-08-27
D77810701992Scott's Select Cotton RollsSCOTT'S DENTAL SUPPLY L.L.C.EFN2024-08-27
10304040184803Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10304040184810Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10304040184827Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10304040184858Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10304040184865Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184806Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184813Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184820Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184851Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184868Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10850053289535SURGYCOSurgyco LLCEFN2024-08-09
10850053289542SURGYCOSurgyco LLCEFN2024-08-09
00850053289538SURGYCOSurgyco LLCEFN2024-08-09