FDA.reportPublic FDA data

Symmetry Rumel

Primary DI
00887482083857
Brand
Symmetry Rumel
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
55-5499
Catalog number
55-5499
Device description
Symmetry® Obturator, Rumel, Child
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
EYRTourniquet, Gastro-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYRTourniquet, Gastro-UrologyGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482083857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482083857008874820838578874820838570887482083857

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube obturatorA device designed to fill the lumen of a tracheostomy tube during its insertion into the stoma created in the larynx (windpipe) to assist in this process, reduce patient trauma, and prevent any tissue damage. When the tracheostomy tube is correctly positioned the obturator is removed. It is typically a thin rod with a bulbous rounded distal end that protrudes out of the tracheostomy tube, and a knob-like handle used to remove it. It is typically made of a high-grade stainless steel and/or silver (Ag) or silver plated brass. 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
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
00841785112812Symmetry Olsen08-0089I08-0089I2018-05-22
00841785113321Symmetry Olsen08-009008-00902018-08-22
00887482139806Symmetry Malis®08-0089I08-0089I2016-05-24
00887482139820Symmetry Malis®08-009008-00902016-05-24
00841785112539Symmetry Olsen08-004508-00452017-11-02
00841785112805Symmetry Olsen08-008908-00892018-05-22
00841785113338Symmetry Olsen08-0047I08-0047I2018-08-22
00887482139547Symmetry Semkin08-004508-00452016-05-04
00887482139561Symmetry Hardy™08-0047I08-0047I2016-05-26
00887482139578Symmetry Surgical08-004808-00482016-05-26
00887482139653Symmetry Surgical08-005908-00592016-05-26
00887482139790Symmetry Malis®08-008908-00892016-05-17
00841785112317Symmetry Olsen08-0000I08-0000I2017-11-02
00841785112331Symmetry Olsen08-000108-00012017-11-02
00841785112348Symmetry Olsen08-0001I08-0001I2017-11-02
00841785112355Symmetry Olsen08-000408-00042017-11-02
00841785112362Symmetry Olsen08-0004I08-0004I2017-11-02
00841785112379Symmetry Olsen08-000508-00052017-11-02
00841785112393Symmetry Olsen08-000708-00072017-11-02
00841785112423Symmetry Olsen08-000908-00092017-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887482043622Symmetry RumelASPEN SURGICAL PRODUCTS, INC.EYR2024-08-12
00190776290498MILLENNIUMAvalign Technologies, Inc.EYR2023-09-28
00190776334734MILLENNIUMAvalign Technologies, Inc.EYR2023-09-28
00190776370060MILLENNIUMAvalign Technologies, Inc.EYR2023-09-28
14026704795670PILLINGTELEFLEX INCORPORATEDEYR2022-12-08
14026704795694PILLINGTELEFLEX INCORPORATEDEYR2022-12-08
54026704795678PILLINGTELEFLEX INCORPORATEDEYR2022-12-08
14026704795700PILLINGTELEFLEX INCORPORATEDEYR2022-12-08
14026704795687PILLINGTELEFLEX INCORPORATEDEYR2022-12-08
54026704795692PILLINGTELEFLEX INCORPORATEDEYR2022-12-08
00190776055837AvalignAvalign Technologies, Inc.EYR2021-11-03
00190776055844AvalignAvalign Technologies, Inc.EYR2021-11-03
00190776055868AvalignAvalign Technologies, Inc.EYR2021-11-03
00190776055875AvalignAvalign Technologies, Inc.EYR2021-11-03
00190776055882AvalignAvalign Technologies, Inc.EYR2021-11-03
00190660111786Ambler SurgicalAMBLER SURGICAL CORP.EYR2021-01-07
00190660111793Ambler SurgicalAMBLER SURGICAL CORP.EYR2021-01-07
00190660111809Ambler SurgicalAMBLER SURGICAL CORP.EYR2021-01-07
00190660111816Ambler SurgicalAMBLER SURGICAL CORP.EYR2021-01-07
00190660111823Ambler SurgicalAMBLER SURGICAL CORP.EYR2021-01-07
00190660111830Ambler SurgicalAMBLER SURGICAL CORP.EYR2021-01-07
00190660111847Ambler SurgicalAMBLER SURGICAL CORP.EYR2021-01-07
00190660111854Ambler SurgicalAMBLER SURGICAL CORP.EYR2021-01-07
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10381780191025Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEYR2018-03-02
10381780457862Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEYR2018-03-02
10381780457879Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEYR2018-03-02
M2743055001Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEYR2018-03-02
M2743055011Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEYR2018-03-02
M2743054981Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEYR2018-03-02