FDA.reportPublic FDA data

Cotton Balls

Primary DI
20749915000654
Brand
Cotton Balls
Company
AMERICAN SURGICAL COMPANY, LLC
Model
31-04
Device description
"Cotton Balls-Non-Strung 1"""
Published
2016-06-07
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
GDYGauze/Sponge, Internal, X-Ray Detectable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDYGauze/Sponge, Internal, X-Ray DetectableGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K854714000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K854714000X-RAY DETECTABLE COTTON BALLSAmerican Silk Sutures, Inc.1985-12-17GDY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20749915000654PrimaryGS10
10749915000657Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2074991500065420749915000654
1074991500065710749915000657

GMDN Terms#

Term, Definition table
TermDefinition
Cotton ballA device designed as an absorbent, non-sterile spherical mass of cotton or man-made fibres used as a swab to apply medications to or remove fluid/liquid from various parts of the body. It is used within the healthcare sector or the home and is normally available [non-prescription] over-the-counter (OTC). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
151054954
Device count
20
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
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
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
10810178830005Tally Surgical SolutionTally Surgical, Inc.GDY2025-02-18
10197106760994CARDINAL HEALTHCardinal Health 200, LLCGDY2025-01-29
10080196031313MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-01-16
10080196743926MEDLINEMEDLINE INDUSTRIES, INC.GDY2024-10-15
10326053119504Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119511Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119528Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119535Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119542Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09