FDA.reportPublic FDA data

Symmetry Ferguson

Primary DI
00887482056462
Brand
Symmetry Ferguson
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
16-3919
Catalog number
16-3919
Device description
Symmetry® Clamp, Ferguson Angiotribe
Published
2024-08-07
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
GDJClamp, Surgical, General & Plastic Surgery
GZTRetractor, Self-Retaining, For Neurosurgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDJClamp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1
GZTRetractor, Self-Retaining, For NeurosurgeryNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161004000Self-retaining RetractorFetzer Medical GmbH & Co. KG2016-09-09GZT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482056462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482056462008874820564628874820564620887482056462

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue surgical hook, reusableA hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. 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
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
00190776434458MillenniumAvalign Technologies, Inc.GZT2026-10-07
00190776434465MillenniumAvalign Technologies, Inc.GZT2026-10-07
00810220800591Adler Instrument CompanyAdler, Inc.GZT2026-10-07
00810220800607Adler Instrument CompanyAdler, Inc.GZT2026-10-07
00810220800614Adler Instrument CompanyAdler, Inc.GZT2026-10-07
00190776433017MillenniumAvalign Technologies, Inc.GDJ2026-10-01
00190776433109MillenniumAvalign Technologies, Inc.GDJ2026-10-01
00190776432584MillenniumAvalign Technologies, Inc.GDJ2026-09-28
00190776430993MillenniumAvalign Technologies, Inc.GDJ2026-09-18
00190776420406MillenniumAvalign Technologies, Inc.GZT2026-08-26
00190776417239MillenniumAvalign Technologies, Inc.GZT2026-08-19
00190776426705MillenniumAvalign Technologies, Inc.GDJ2026-08-19
00190776416997MillenniumAvalign Technologies, Inc.GZT2026-08-18
00724995355296V. MuellerSteris CorporationGZT2026-08-18
00724995355319V. MuellerSteris CorporationGZT2026-08-18
00724995355340V. MuellerSteris CorporationGZT2026-08-18
00724995355364V. MuellerSteris CorporationGZT2026-08-18
00724995355388V. MuellerSteris CorporationGZT2026-08-18
00850088713459PRINCETONPrinceton Medical Group, Inc.GDJ2026-08-14
00850088713466PRINCETONPrinceton Medical Group, Inc.GDJ2026-08-14
00850088713527PRINCETONPrinceton Medical Group, Inc.GDJ2026-08-14
00190776424497MillenniumAvalign Technologies, Inc.GDJ2026-08-07
00190776408756MillenniumAvalign Technologies, Inc.GZT2026-08-03
03701089543286AMPLITUDEAMPLITUDE SASGDJ2026-07-29
00190776422196MillenniumAvalign Technologies, Inc.GDJ2026-07-28
B382SD9055891030Surgical DirectSurgical Direct, Inc.GDJ2026-07-28
B382SD905589105T0Surgical DirectSurgical Direct, Inc.GDJ2026-07-28
00859261006265VBAS Extension ArmVYCOR MEDICAL, INC.GDJ2026-07-27
00190776402167MillenniumAvalign Technologies, Inc.GZT2026-07-21
04059453072832Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDJ2026-07-13