FDA.report

SAFE DENT

Primary DI
00854014003379
Brand
SAFE DENT
Company
BGSS Company Inc.
Model
CF6014
Device description
CF6014 2X2 8 PLY COTTON FILLED GAUZE- SLEEVE
Published
2024-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EFNCotton, Roll

Product Code Classifications

CodeDeviceSpecialtyClass
EFNCotton, RollDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00854014003379PackageGS125In Commercial Distribution
00854014003362PrimaryGS10
00854014003355Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00854014003379008540140033798540140033790854014003379
00854014003362008540140033628540140033620854014003362
00854014003355008540140033558540140033550854014003355

GMDN Terms

TermDefinition
Non-woven gauze padA non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
828474952
Device count
200
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810339030100SAFE DENTP50192024-05-15
00810339030322SAFE DENTM3010BL2024-05-15
00810339031138SAFE DENTM3011PK2024-05-15
00810339031398SAFE DENTH501392024-05-15
00810339031657SAFE DENTH501382024-05-15
00810339031831SAFE DENTLAB201M-BL2024-05-15
00810339031862SAFE DENTLAB202L-BL2024-05-15
00810339031893SAFE DENTLAB203XL-BL2024-05-15
00854014003034SAFE DENTSTP-7001-A2024-05-15
00854014003065SAFE DENTSTP-7002-B2024-05-15
00854014003096SAFE DENTSTP-7003-C2024-05-15
00854014003126SAFE DENTSTP-7004-D2024-05-15
00854014003157SAFE DENTSTP-7004-E2024-05-15
00854014003188SAFE DENTSTP-7006-F2024-05-15
00854014003645SAFE DENTPT8112W2024-05-15
00854014003683SAFE DENTPT8113BL2024-05-15
00854014003720SAFE DENTPT8114DR2024-05-15
00854014003751SAFE DENTPT8115LV2024-05-15
00854014003812SAFE DENTPT8117MG2024-05-15
00810339030018SAFE DENTP50132024-05-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810194401794AiraAIRA, LLCEFN2026-01-16
00810124536909Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyEFN2025-12-05
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
20810132044285HCS SourcingConcordance Healthcare Solutions LLCEFN2025-04-07
20810132044278HCSConcordance Healthcare Solutions LLCEFN2025-03-05
D77810701992Scott's Select Cotton RollsSCOTT'S DENTAL SUPPLY L.L.C.EFN2024-08-27
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
00850053289538SURGYCOSurgyco LLCEFN2024-08-09
00850053289545SURGYCOSurgyco LLCEFN2024-08-09
00304040184837Henry ScheinHENRY SCHEIN, INC.EFN2024-06-26
00304040184844Henry ScheinHENRY SCHEIN, INC.EFN2024-06-26
00854014003270SAFE DENTBGSS Company Inc.EFN2024-05-01
00854014003300SAFE DENTBGSS Company Inc.EFN2024-05-01
00854014003348SAFE DENTBGSS Company Inc.EFN2024-05-01
20815878025321Burkhart Non-Woven SpongesCROSSTEX INTERNATIONAL, INC.EFN2024-04-09
20815878027585Burkhart Non-Woven SpongesCROSSTEX INTERNATIONAL, INC.EFN2024-04-09
20815878028483Burkhart Non-Woven SpongesCROSSTEX INTERNATIONAL, INC.EFN2024-04-09
00653078997552Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyEFN2023-12-15
00810124531225Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyEFN2023-12-15
00810124531218Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyEFN2023-12-15
D79620001MARK3CARGUS INTERNATIONAL, INCEFN2023-08-01
06974669350353MDHCMDHC Life Technologies (Kunshan) Co., LTD.EFN2023-07-06