FDA.reportPublic FDA data

Symmetry House

Primary DI
00887482113769
Brand
Symmetry House
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
61-0364
Catalog number
61-0364
Device description
Symmetry® Guide, House Wire Strut, w/Notched End, 0.6 mm Tip, Straight Shaft, 6 1/2 in
Published
2024-08-12
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
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482113769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482113769008874821137698874821137690887482113769

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-urological guidewire, reusableA metal coil or wire intended to to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6.5Inch
Width0.6Millimeter

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
00887482156667Symmetry53-1675RC2026-09-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06932503563857Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
06932503563864Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
06932503563871Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
00810056993139corraCarlsmed, Inc.FZX2026-01-30
00810112590036MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590043MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590050MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590067MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590098MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590104MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590128MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590135MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590142MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590180MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590197MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590203MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590210MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590227MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590234MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590241MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590258MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590265MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590272MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590289MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590319MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590326MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590333MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590357MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590364MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590371MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05