FDA.reportPublic FDA data

Symmetry Surgical®

Primary DI
00887482074640
Brand
Symmetry Surgical®
Company
SYMMETRY SURGICAL INC.
Model
50-7615
Catalog number
50-7615
Device description
Symmetry® Speculum, Brinkerhoff Rectal, Medium, 4 in
Published
2022-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FXESpeculum, Non-Illuminated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXESpeculum, Non-IlluminatedGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482074640PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482074640008874820746408874820746400887482074640

GMDN Terms#

Term, Definition table
TermDefinition
Rectal speculumA hand-held manual surgical instrument intended to be used to expand or stretch the rectal orifice/canal after it is inserted and opened. It is comprised of two arms joined at a pivot point and is available in various sizes, shapes, and contours; it is usually made of stainless steel. The instrument is used for examination or for the insertion of other instrumentation. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Inch

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
079641356
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887482196533Symmetry Barraquer60-1906-SYM60-1906-SYM2025-07-24
00887482196540Symmetry Castroviejo60-1910-SYM60-1910-SYM2025-07-24
00887482012307Symmetry Tyrell 38-652538-65252022-09-16
00887482006559Symmetry Surgical32-348532-34852024-09-05
00887482006566Symmetry Surgical32-348532-34852024-09-05
00887482196793Symmetry Surgical90-1042R90-1042R2024-09-05
00887482030578Symmetry Hardy80-133080-13302024-09-05
00887482030585Symmetry Hardy80-133180-13312024-09-05
00887482030592Symmetry Hardy80-133280-13322024-09-05
00887482030608Symmetry Hardy80-133380-13332024-09-05
00887482030615Symmetry Hardy80-133480-13342024-09-05
00887482030622Symmetry Hardy80-133580-13352024-09-05
00887482030707Symmetry Hardy80-134580-13452024-09-05
00887482030714Symmetry Hardy80-134680-13462024-09-05
00887482030721Symmetry Hardy80-134780-13472024-09-05
00887482030738Symmetry Hardy80-134880-13482024-09-05
00887482031124Symmetry Verity™80-153680-15362024-09-05
00887482031506Symmetry Rhoton®80-169280-16922024-09-05
00887482031513Symmetry Rhoton®80-169380-16932024-09-05
00887482116203Symmetry Paparella61-377561-37752024-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810158218888PRINCETONPrinceton Medical Group, Inc.FXE2026-02-16
00810158218895PRINCETONPrinceton Medical Group, Inc.FXE2026-02-16
00810158218901PRINCETONPrinceton Medical Group, Inc.FXE2026-02-16
00810158218178PRINCETONPrinceton Medical Group, Inc.FXE2025-12-15
00810158218185PRINCETONPrinceton Medical Group, Inc.FXE2025-12-15
00810158218192PRINCETONPrinceton Medical Group, Inc.FXE2025-12-15
00194613065607MSI Precision Specialty InstrumentsMed Saver, Inc.FXE2025-08-01
00194613104726MSI Precision Specialty InstrumentsMed Saver, Inc.FXE2025-08-01
00194613120290MSI Precision Specialty InstrumentsMed Saver, Inc.FXE2025-08-01
00810158214699PRINCETONPrinceton Medical Group, Inc.FXE2025-03-31
00810158214705PRINCETONPrinceton Medical Group, Inc.FXE2025-03-31
00192896100671TEALE GORGETSONTEC INSTRUMENTS, INC.FXE2025-02-24
00190776390167MillenniumAvalign Technologies, Inc.FXE2024-05-31
G586N6867570Novo SurgicalNOVO SURGICAL, INC.FXE2023-12-18
G586N6867580Novo SurgicalNOVO SURGICAL, INC.FXE2023-12-18
G586N6867590Novo SurgicalNOVO SURGICAL, INC.FXE2023-12-18
G586N6867610Novo SurgicalNOVO SURGICAL, INC.FXE2023-12-18
00190776041786AvalignAvalign Technologies, Inc.FXE2023-11-13
00192896115750Teales Gorget SpeculumSONTEC INSTRUMENTS, INC.FXE2023-11-03
00190776316471MILLENNIUMAvalign Technologies, Inc.FXE2023-09-28
00842962137956HNM MEDICALHNM STAINLESS, LLC.FXE2023-04-02
00842962137963HNM MEDICALHNM STAINLESS, LLC.FXE2023-04-02
00842962137970HNM MEDICALHNM STAINLESS, LLC.FXE2023-04-02
00842962119150HNM MEDICALHNM STAINLESS, LLC.FXE2023-03-30
54026704792219PILLINGTELEFLEX INCORPORATEDFXE2022-12-08
54026704792226PILLINGTELEFLEX INCORPORATEDFXE2022-12-08
00842331180996Novo Surgical Inc. NOVO SURGICAL, INC.FXE2022-11-14
00842331187896Novo Surgical Inc. NOVO SURGICAL, INC.FXE2022-11-14
00842331187902Novo Surgical Inc. NOVO SURGICAL, INC.FXE2022-11-14
00842331163739Novo Surgical Inc. NOVO SURGICAL, INC.FXE2022-11-13