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
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
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