FDA.reportPublic FDA data

Symmetry Dingman

Primary DI
00887482122679
Brand
Symmetry Dingman
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
72-0801
Catalog number
72-0801
Device description
Symmetry® Frame, Dingman Mouth Gag Frame Only
Published
2022-10-13
Public version status
Update
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
00887482122679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482122679008874821226798874821226790887482122679

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
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 888-364-7004customerservice@symmetrysurgical.com

Regulatory Flags#

DUNS number
027680821
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841785112812Symmetry Olsen08-0089I08-0089I2018-05-22
00841785113321Symmetry Olsen08-009008-00902018-08-22
00887482139806Symmetry Malis®08-0089I08-0089I2016-05-24
00887482139820Symmetry Malis®08-009008-00902016-05-24
00841785112539Symmetry Olsen08-004508-00452017-11-02
00841785112805Symmetry Olsen08-008908-00892018-05-22
00841785113338Symmetry Olsen08-0047I08-0047I2018-08-22
00887482139547Symmetry Semkin08-004508-00452016-05-04
00887482139561Symmetry Hardy™08-0047I08-0047I2016-05-26
00887482139578Symmetry Surgical08-004808-00482016-05-26
00887482139653Symmetry Surgical08-005908-00592016-05-26
00887482139790Symmetry Malis®08-008908-00892016-05-17
00841785112317Symmetry Olsen08-0000I08-0000I2017-11-02
00841785112331Symmetry Olsen08-000108-00012017-11-02
00841785112348Symmetry Olsen08-0001I08-0001I2017-11-02
00841785112355Symmetry Olsen08-000408-00042017-11-02
00841785112362Symmetry Olsen08-0004I08-0004I2017-11-02
00841785112379Symmetry Olsen08-000508-00052017-11-02
00841785112393Symmetry Olsen08-000708-00072017-11-02
00841785112423Symmetry Olsen08-000908-00092017-11-02

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