FDA.reportPublic FDA data

Symmetry Surgical®

Primary DI
00887482044667
Brand
Symmetry Surgical®
Company
SYMMETRY SURGICAL INC.
Model
50-7716
Catalog number
50-7716
Device description
Symmetry® Speculum, Hirschmann Rectal, Small, 2 3/8 in, 9/16 in Diameter
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
FFQSpeculum, Rectal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFQSpeculum, RectalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482044667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482044667008874820446678874820446670887482044667

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
Device Size Text, specify0
Width2.375Inch

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
00198506087691ELMED INCORPORATEDELMED INCORPORATEDFFQ2026-01-16
00198506085376ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-09-09
00198506085017ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-09-05
00190776409180MillenniumAvalign Technologies, Inc.FFQ2025-08-22
00190776409265MillenniumAvalign Technologies, Inc.FFQ2025-08-22
00190776409272MillenniumAvalign Technologies, Inc.FFQ2025-08-22
00190776408299MillenniumAvalign Technologies, Inc.FFQ2025-08-07
00198506084201ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-07-17
00190776402983MillenniumAvalign Technologies, Inc.FFQ2025-06-30
00190776399627MillenniumAvalign Technologies, Inc.FFQ2025-06-02
00190776399634MillenniumAvalign Technologies, Inc.FFQ2025-06-02
00190776399764MillenniumAvalign Technologies, Inc.FFQ2025-06-02
04049047074663GimmiGimmi GmbHFFQ2025-05-20
04049047074670GimmiGimmi GmbHFFQ2025-05-20
04049047316848GimmiGimmi GmbHFFQ2025-05-20
00190776393717MillenniumAvalign Technologies, Inc.FFQ2025-05-06
00190776393724MillenniumAvalign Technologies, Inc.FFQ2025-05-06
00190776393731MillenniumAvalign Technologies, Inc.FFQ2025-05-06
00190776393748MillenniumAvalign Technologies, Inc.FFQ2025-05-06
00190776393755MillenniumAvalign Technologies, Inc.FFQ2025-05-06
00198506082610ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-05-06
00190776393182MillenniumAvalign Technologies, Inc.FFQ2025-05-05
00198506082375ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-04-21
00198506081248ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-03-14
00198506075537ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-02-21
00198506074066ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-01-03
00198506073816ELMED INCORPORATEDELMED INCORPORATEDFFQ2024-12-19
00190776389918MillenniumAvalign Technologies, Inc.FFQ2024-11-18
00190776389130MillenniumAvalign Technologies, Inc.FFQ2024-11-14
00198506073243ELMED INCORPORATEDELMED INCORPORATEDFFQ2024-11-11