FDA.reportPublic FDA data

Symmetry Carley

Primary DI
00887482118801
Brand
Symmetry Carley
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
63-7419
Catalog number
63-7419
Device description
Symmetry® Backbiter, Carley Rotating
Published
2024-08-20
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
KTFPunch, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTFPunch, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482118801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482118801008874821188018874821188010887482118801

GMDN Terms#

Term, Definition table
TermDefinition
ENT soft-tissue cutting forcepsA hand-held manual surgical instrument with a biting action intended to be used to punch/cut/excise soft-tissue during an ear/nose/throat (ENT) procedure [e.g., adenoidectomy, tonsillectomy, sinus surgery, septoplasty, and/or biopsy]. It is a metallic instrument with a distal mechanism designed to bite tissue when the handles are squeezed together; some types may be used endoscopically (e.g., through a laryngopharyngoscope), and may include an integrated fluid suction channel for improved surgical field viewing. It is not intended for cutting bone (i.e., not a rongeur). 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
10840113232908BovieAA002026-09-21
10840113232922BovieAA00X2026-09-21
10840113232946BovieAA012026-09-21
10840113232960BovieAA01X2026-09-21
10840113232984BovieAA022026-09-21
10840113233004BovieAA032026-09-21
10840113233028BovieAA03X2026-09-21
10840113233042BovieAA042026-09-21
10840113233066BovieAA04X2026-09-21
10840113233080BovieAA052026-09-21
10840113233165BovieAA212026-09-21
10840113233189BovieAA21X2026-09-21
10840113233264BovieAA902026-09-21
10840113233547BovieAA05X2026-09-21
10840113234407BovieES232026-09-21
10840113234414BovieES22-82026-09-21
10840113236838BovieES032026-09-21
10840113236845BovieES022026-09-21
10840113236852BovieES02T2026-09-21
10840113236876BovieES012026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462900404evonosevonos GmbH & Co. KGKTF2026-08-18
04054462905829evonosevonos GmbH & Co. KGKTF2026-08-18
04054462905843evonosevonos GmbH & Co. KGKTF2026-08-18
04054462905850evonosevonos GmbH & Co. KGKTF2026-08-18
04054462908912evonosevonos GmbH & Co. KGKTF2026-08-18
04054462915163evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915170evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915187evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915194evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915200evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915217evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915224evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915231evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915248evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915255evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915262evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915279evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915286evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915293evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915309evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915316evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915323evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915347evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915354evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915361evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915378evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915385evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915392evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915408evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915415evonosevonos GmbH & Co. KGKTF2026-08-17