FDA.reportPublic FDA data

Symmetry Saalfeld

Primary DI
00887482073346
Brand
Symmetry Saalfeld
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
43-3185
Catalog number
43-3185
Device description
Ultra Instruments® Extractor, Saalfeld Comedone, w/Lancet, 6 in
Published
2024-08-20
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
NJZExtractor, Vein

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJZExtractor, VeinGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482073346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482073346008874820733468874820733460887482073346

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic working-channel cannula, reusableA rigid tube designed to create a channel through the sclera for internal ocular access during posterior segment ophthalmic surgery. It is typically made of plastic materials or high-grade stainless steel and enables the introduction of ophthalmic surgical instruments; it may also be used for irrigation (i.e., the infusion of fluids to maintain the interior pressure of the eye during surgery). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-888-364-7004customerservice@symmetrysurgical.com
+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
07898506835720QuinelatoSchobell Industrial LtdaNJZ2023-01-11
07898506835737QuinelatoSchobell Industrial LtdaNJZ2023-01-11
07898506835744QuinelatoSchobell Industrial LtdaNJZ2023-01-11
07898506835751QuinelatoSchobell Industrial LtdaNJZ2023-01-11
07898506835768QuinelatoSchobell Industrial LtdaNJZ2023-01-11
07898506835775QuinelatoSchobell Industrial LtdaNJZ2023-01-11
07898506835782QuinelatoSchobell Industrial LtdaNJZ2023-01-11
00840183514884BR Surgical, LLCBR Surgical, LLCNJZ2022-11-22
B97450473207Vein HookDR.FRIGZ INTERNATIONAL(PVT)LTD,NJZ2022-11-21
00616784420516Venom Extractor KitsDynarex CorporationNJZ2020-11-02