FDA.reportPublic FDA data

Symmetry Osher-Neumann

Primary DI
00887482112519
Brand
Symmetry Osher-Neumann
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
60-8038
Catalog number
60-8038
Device description
Symmetry Marker; Osher Neumann Corneal Radial Keratotomy Ophthalmic; 8 Blades; 4.5 mm; 4 1/4 in
Published
2017-12-21
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
FZZMarker, Skin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZZMarker, SkinGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482112519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482112519008874821125198874821125190887482112519

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during an open surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle because it is available in a variety of lengths and sizes. It is made of high-grade stainless steel. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4.25Inch

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
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00841439115251Opti-TattQfixFZZ2026-05-29
16931918101040AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
16931918108414AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
16931918152356AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
16931918161327AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
16931918172934AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
10080196771844MEDLINEMEDLINE INDUSTRIES, INC.FZZ2026-01-12
40080196312710MEDLINEMEDLINE INDUSTRIES, INC.FZZ2026-01-12
40080196312741MEDLINEMEDLINE INDUSTRIES, INC.FZZ2026-01-12
10198956206045CARDINAL HEALTHCardinal Health 200, LLCFZZ2025-11-07
00661392004511LSL HEALTHCARELSL Industries, LLCFZZ2025-10-30
00661392004528LSL HEALTHCARELSL Industries, LLCFZZ2025-10-30
10080196771851MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12
10884389025949MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12
10884389711798MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12
10884389362402MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-10
00754027700275RMAC SurgicalRMAC Surgical, IncFZZ2025-06-03
10080196326006MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-02
10198459271694Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FZZ2025-02-23
00714646001290IsoMark™Bionix, LLCFZZ2025-02-20
10884389610312Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FZZ2024-08-04
10080196031436Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FZZ2024-07-29
10197106628232CARDINAL HEALTHCardinal Health 200, LLCFZZ2024-05-07
10860010334574InkWell Health Inkwell Health LtdFZZ2023-12-14
10884389106358MedlineMEDLINE INDUSTRIES, INC.FZZ2023-12-11
20193489027218MedlineMEDLINE INDUSTRIES, INC.FZZ2023-12-11
10884389025925MedlineMEDLINE INDUSTRIES, INC.FZZ2023-10-13