FDA.reportPublic FDA data

Darby Dental Supply, LLC

Primary DI
00889813038895
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
9517155
Catalog number
9517155
Device description
MOUTH GAG CHILD WITH TIPS DARBY
Published
2020-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KBNGAG, MOUTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBNGag, MouthEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889813038895PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813038895008898130388958898130388950889813038895

GMDN Terms#

Term, Definition table
TermDefinition
Mouth gag, adjustable, reusableA mechanical device with adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral/dental surgical intervention. Also known as a jaw spreader, it is available in various designs having support structures that force and/or hold the jaws apart; e.g., it may be designed with flat, pivoted blades that angle outward when adjusted; or it may have two parallel plates that move apart with adjustments to a centre screw; or it may have a scissors-like design with pivoted, self-retaining, notched blades at the distal end. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(516)688-6800Robyn.livingston@darby.com

Regulatory Flags#

DUNS number
825137818
Device count
1
Premarket exempt
true
Lot or batch
true

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
00190776418489MillenniumAvalign Technologies, Inc.KBN2026-04-06
14026704810069PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
14026704810076PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
14026704810083PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
14026704810090PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
14026704810106PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
14026704810113PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
14026704810120PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
ESAM4011541STOMA®Storz am Mark GmbHKBN2022-11-07
ESAM3725121STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM3740111STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM3740141STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM4033001STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM4033011STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM4033021STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM4033031STOMA®Storz am Mark GmbHKBN2020-08-27
10889950015695Hu-FriedyHU-FRIEDY MFG. CO., LLCKBN2020-08-14
10889950015701Hu-FriedyHU-FRIEDY MFG. CO., LLCKBN2020-08-14
10889950015718Hu-FriedyHU-FRIEDY MFG. CO., LLCKBN2020-08-14
10381780448822Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-10-23
14026704630742PILLINGTELEFLEX INCORPORATEDKBN2018-10-22
24026704600322PillingTELEFLEX INCORPORATEDKBN2018-09-15
24026704600339PillingTELEFLEX INCORPORATEDKBN2018-09-15
10381780506485Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-09-12
10381780507857Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-09-12
10381780487807Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-08-29
10381780487814Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-08-20
10381780487821Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-08-20
10381780487845Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-08-20
10381780437963Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-08-16