FDA.reportPublic FDA data

Darby Dental Supply, LLC

Primary DI
10889813062415
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
5256904
Device description
CSR WRAP 15X15 BLUE DARBY
Published
2024-09-17
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

Product Codes#

Code, Name table
CodeName
FRGWrap, sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889813062418PrimaryGS10
10889813062415Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813062418008898130624188898130624180889813062418
1088981306241510889813062415

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
825137818
Device count
500
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889813067970Darby Dental Supply, LLC95377462026-03-22
00889813067987Darby Dental Supply, LLC95377502026-03-22
00889813067994Darby Dental Supply, LLC525879552587952026-02-12
00889813068007Darby Dental Supply, LLC525879652587962026-02-12
00889813068021Darby Dental Supply, LLC525879752587972026-02-12
00889813068038Darby Dental Supply, LLC525879852587982026-02-12
00889813068045Darby Dental Supply, LLC525879952587992026-02-12
00889813068052Darby Dental Supply, LLC525879052587902026-02-12
00889813068069Darby Dental Supply, LLC525879152587912026-02-12
00889813068076Darby Dental Supply, LLC525879252587922026-02-12
00889813068083Darby Dental Supply, LLC525879352587932026-02-12
00889813068090Darby Dental Supply, LLC525879452587942026-02-12
00889813048566Darby Dental Supply, LLC943020394302032022-07-18
00889813048580Darby Dental Supply, LLC943020494302042022-07-18
00889813048610Darby Dental Supply, LLC943020594302052022-07-18
00889813048672Darby Dental Supply, LLC943021094302102022-07-18
00889813048696Darby Dental Supply, LLC943021194302112022-07-18
00889813048719Darby Dental Supply, LLC943021294302122022-07-18
00889813048443Darby Dental Supply, LLC943020294302022022-07-18
00889813048511Darby Dental Supply, LLC943020194302012022-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08404535029437Brasseler USAPeter Brasseler Holdings, LLCFRG2026-05-13
08404535025927Brasseler USAPeter Brasseler Holdings, LLCFRG2026-05-01
08404535015003Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
08404535019100Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
08404535025217Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
08404535025248Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
08404535025279Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
10197344140008MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10197344140015MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10197344140022MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10197344149018MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10197344149025MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10197344149032MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10198459366277MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FRG2025-06-16
10197344695331MEDLINEMEDLINE INDUSTRIES, INC.FRG2024-09-26
10197344695348MEDLINEMEDLINE INDUSTRIES, INC.FRG2024-09-26
10197344695355MEDLINEMEDLINE INDUSTRIES, INC.FRG2024-09-26
10197344695362MEDLINEMEDLINE INDUSTRIES, INC.FRG2024-09-26
10197344695379MEDLINEMEDLINE INDUSTRIES, INC.FRG2024-09-26
10304040172046Henry ScheinHENRY SCHEIN, INC.FRG2023-09-08
10304040172053Henry ScheinHENRY SCHEIN, INC.FRG2023-09-08
10686864044786Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
10686864044793Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
10686864044809Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
10686864044816Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
10686864044823Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
10686864044830Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
10686864044847Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
H66810503101PrehmaKeystone IndustriesFRG2023-02-20
H66810504101PrehmaKeystone IndustriesFRG2023-02-20