FDA.reportPublic FDA data

Symmetry Rhoton®

Primary DI
00887482103593
Brand
Symmetry Rhoton®
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
58-6040
Catalog number
58-6040
Device description
Rhoton® Needle, Straight, Semi-Sharp, 7 1/2 in
Published
2024-08-01
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
HASNeedle, Neurosurgical Suture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HASNeedle, Neurosurgical SutureNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482103593PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482103593008874821035938874821035930887482103593

GMDN Terms#

Term, Definition table
TermDefinition
Body aspiration needle, reusableA sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7.5Inch

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
00840113233281BovieH1002026-09-04
00840113233304BovieH1012026-09-04
00840113233328BovieH101-ADH2026-09-04
00840113233342BovieH1032026-09-04
00840113233366BovieH1042026-09-04
00840113233380BovieH1052026-09-04
00840113233403BovieH1062026-09-04
00840113233427BovieH1092026-09-04
00840113233441BovieH1102026-09-04
00840113233465BovieH1112026-09-04
00840113233489BovieH1122026-09-04
00840113233502BovieH1212026-09-04
00840113233526BovieHISL2026-09-04
00840113237326BovieESP1N2026-09-04
00840113237340BovieESP1H2026-09-04
00840113237593BovieESP7N2026-09-04
00840113237623BovieESP7H2026-09-04
00840113237661BovieESP6N2026-09-04
00840113237692BovieESP6H2026-09-04
00840113242573BovieST052026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262494463051N/ADoppkon GmbH & Co. KGHAS2025-12-04
00887482103579Symmetry Rhoton®ASPEN SURGICAL PRODUCTS, INC.HAS2024-09-05
00190776354619MILLENNIUMAvalign Technologies, Inc.HAS2023-09-28
00190776355067MILLENNIUMAvalign Technologies, Inc.HAS2023-09-28
14026704796929PILLINGTELEFLEX INCORPORATEDHAS2022-12-08
54026704796927PILLINGTELEFLEX INCORPORATEDHAS2022-12-08
00887482096215Symmetry AdsonASPEN SURGICAL PRODUCTS, INC.HAS2022-08-24
00190776068585AvalignAvalign Technologies, Inc.HAS2021-11-03
00190776068592AvalignAvalign Technologies, Inc.HAS2021-11-03
00190776211912AvalignAvalign Technologies, Inc.HAS2021-11-03
00190660121549Ambler SurgicalAMBLER SURGICAL CORP.HAS2021-01-07
00190660121556Ambler SurgicalAMBLER SURGICAL CORP.HAS2021-01-07
00190660109707Ambler SurgicalAMBLER SURGICAL CORP.HAS2021-01-04
00190660121563Ambler SurgicalAMBLER SURGICAL CORP.HAS2021-01-04
00190660121570Ambler SurgicalAMBLER SURGICAL CORP.HAS2021-01-04
10885403072819V. MuellerSTERIS CORPORATIONHAS2018-08-30