FDA.report

SAFE DENT

Primary DI
00810339030100
Brand
SAFE DENT
Company
BGSS Company Inc.
Model
P5019
Device description
T HANDLE SLEEVES
Published
2024-05-15
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
NRDUnit, Operative Dental, Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810339030100PackageGS124In Commercial Distribution
00810339030094PrimaryGS10
00810339030087Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810339030100008103390301008103390301000810339030100
00810339030094008103390300948103390300940810339030094
00810339030087008103390300878103390300870810339030087

GMDN Terms

TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
828474952
Device count
500
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
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
00810339030049SAFE DENTP5016XL2024-05-01

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00810126506535Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506559Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506573Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
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