FDA.reportPublic FDA data

Symmetry Inge

Primary DI
00887482041192
Brand
Symmetry Inge
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
57-5505
Catalog number
57-5505
Device description
Symmetry® Spreader, Inge Lamina, Child, 6 1/4 in, 158 mm
Published
2017-12-13
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
FFORetractor, Self-Retaining

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFORetractor, Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482041192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482041192008874820411928874820411920887482041192

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6.25Inch

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
00841785102714Symmetry Olsen20-1040I20-1040I2016-09-09
00841785102769Symmetry Olsen20-106020-10602016-09-06
00841785102776Symmetry Olsen20-1060I20-1060I2016-09-06
00841785102899Symmetry Olsen20-108020-10802016-09-06
00841785102905Symmetry Olsen20-1080I20-1080I2016-09-06
00841785102950Symmetry Olsen20-108220-10822016-09-06
00841785102967Symmetry Olsen20-1082I20-1082I2016-09-06
00841785102974Symmetry Olsen20-1082IMT20-1082IMT2016-09-07
00841785103025Symmetry Olsen20-109020-10902016-09-06
00841785103032Symmetry Olsen20-1090I20-1090I2016-09-06
00841785103049Symmetry Olsen20-1090IMT20-1090IMT2016-09-07
00841785103162Symmetry Olsen20-1162I20-1162I2016-09-06
00841785103285Symmetry Olsen20-1190I20-1190I2016-09-06
00841785103667Symmetry Olsen20-1325I20-1325I2016-09-08
00841785103674Symmetry Olsen20-1325IMT20-1325IMT2016-09-08
00841785103735Symmetry Olsen20-1330I20-1330I2016-09-08
00841785103742Symmetry Olsen20-1330IMT20-1330IMT2016-09-09
00841785103803Symmetry Olsen20-1340I20-1340I2016-09-06
00841785103865Symmetry Olsen20-1350I20-1350I2016-09-06
00841785103988Symmetry Olsen20-1360I20-1360I2016-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811114068INKAThe Trustee for KAISER FAMILY TRUSTFFO2026-05-29
09348811114075INKAThe Trustee for KAISER FAMILY TRUSTFFO2026-05-29
09348811023612INKAThe Trustee for KAISER FAMILY TRUSTFFO2025-11-19
07898506813698QuinelatoSchobell Industrial LtdaFFO2022-12-16
00192896094710INGE LAMINA SPREADER RETRACTORSONTEC INSTRUMENTS, INC.FFO2019-03-07
10381780268437Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-10-23
10381780268420Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780268499Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269397Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269427Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269489Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269564Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269663Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269670Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269694Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269724Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269748Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269762Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269779Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269816Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780268413Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268444Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268451Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268468Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268475Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268482Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268505Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268512Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268529Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268543Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23