FDA.reportPublic FDA data

Symmetry Andrew

Primary DI
00887482049150
Brand
Symmetry Andrew
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
72-0130
Catalog number
72-0130
Device description
Symmetry® Depressor, Andrew Tongue, 17 mm Wide
Published
2024-08-15
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
KBLDepressor, Metal Tongue, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBLDepressor, Metal Tongue, SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482049150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482049150008874820491508874820491500887482049150

GMDN Terms#

Term, Definition table
TermDefinition
Tongue depressor, surgicalA hand-held surgical instrument designed to displace and maintain the tongue in a fixed position, usually by depressing it towards the floor of the mouth. It is typically a metallic (e.g., high-grade stainless steel) device either with a straight shape, or more frequently smoothly bent at its center (e.g., to a 90? arch). The proximal end is used as a handle, while the distal end (usually serrated and may include holes) is used to depress the tongue. The device is used in oral surgery (e.g., during tonsillectomy). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width17Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-888-364-7004customerservice@symmetrysurgical.com
+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
00840113234356BovieA1204C2026-08-17
10840113234728Bovie00032026-08-17
10840113237705BovieESP62026-08-17
10840113237712BovieESP1HN2026-08-17
10840113242426Bovie00022026-08-17
10840113244635Bovie00012026-08-17
10607151008328BovieBVX-LL06T-NSBVX-LL06T-NS2016-09-13
10607151008335BovieBVX-LC04T-NSBVX-LC04T-NS2016-09-13
10607151008342BovieBVX-LB02T-NSBVX-LB02T-NS2016-09-13
10607151008366BovieBVX-LJ07T-NSBVX-LJ07T-NS2016-09-13
10607151008373BovieBVX-LH08T-NSBVX-LH08T-NS2016-09-13
10607151008380BovieBVX-LH01T-NSBVX-LH01T-NS2016-09-13
10607151008397BovieBVX-LN03T-NSBVX-LN03T-NS2016-09-13
10607151011267BovieCS-103T-SDVCS-103T-SDV2016-08-29
10607151011281BovieCS-103T-SVCS-103T-SV2016-08-29
10607151011304BovieCS103T-SVMCS103T-SVM2016-08-29
10607151011311BovieCS-105LEDCS-105LED2016-08-29
10607151011328BovieCS-105T-LEDCS-105T-LED2016-08-29
10607151009905BovieE15626E156262020-11-16
00607151009076BovieLS05LS052016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776417246MillenniumAvalign Technologies, Inc.KBL2026-08-19
00190776397111MillenniumAvalign Technologies, Inc.KBL2026-07-16
09348811004840INKAThe Trustee for KAISER FAMILY TRUSTKBL2025-11-25
09348811004970INKAThe Trustee for KAISER FAMILY TRUSTKBL2025-11-25
00190776407704MillenniumAvalign Technologies, Inc.KBL2025-08-01
00190776407711MillenniumAvalign Technologies, Inc.KBL2025-08-01
00194613046064MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-08-01
00194613049324MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-08-01
00194613049348MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-08-01
00194613049355MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-08-01
00194613049386MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-08-01
00194613049331MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-03-21
00194613107178MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-03-21
00841036058838N/ABIOMET MICROFIXATION, INCKBL2024-09-25
00841036073350N/ABIOMET MICROFIXATION, INCKBL2024-09-25
00841036073367N/ABIOMET MICROFIXATION, INCKBL2024-09-25
00840183517243BR Surgical, LLCBR Surgical, LLCKBL2024-06-10
00840183521714BR Surgical, LLCBR Surgical, LLCKBL2024-06-10
00840183522858BR Surgical, LLCBR Surgical, LLCKBL2024-06-10
00840183522865BR Surgical, LLCBR Surgical, LLCKBL2024-06-10
00840183525422BR Surgical, LLCBR Surgical, LLCKBL2024-06-10
00840183525736BR Surgical, LLCBR Surgical, LLCKBL2024-06-10
10381780538547MicroFrance®INTEGRA MICROFRANCEKBL2024-05-29
G586E831252ES0Novo SurgicalNOVO SURGICAL, INC.KBL2023-12-18
G586E98312510Novo SurgicalNOVO SURGICAL, INC.KBL2023-12-18
G586E98312520Novo SurgicalNOVO SURGICAL, INC.KBL2023-12-18
G586E98313210Novo SurgicalNOVO SURGICAL, INC.KBL2023-12-18
00842331191930Novo Surgical Inc. NOVO SURGICAL, INC.KBL2023-12-07
00190776049034AvalignAvalign Technologies, Inc.KBL2023-09-28
00190776049041AvalignAvalign Technologies, Inc.KBL2023-09-28