FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653013371
Brand
AESCULAP
Company
Aesculap AG
Model
OF015N
Catalog number
OF015N
Device description
LUCAE TUNING FORK C 128
Published
2020-04-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWXFORK, TUNING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWXFork, TuningNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653013371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653013371040386530133714038653013371

GMDN Terms#

Term, Definition table
TermDefinition
Tuning forkA hand-held, mechanical test instrument designed as an acoustic resonator used to test the hearing acuity of a patient, to diagnose hearing disorders, and to test for vibratory sense. It is usually made of stainless steel in the form of a two-pronged fork with the prongs (tines) formed from a U-shaped bar with a handle attached at the base of the "U". It resonates at a specific constant pitch when set vibrating by striking it against a surface or with an object. The pitch that a particular tuning fork generates depends on the length of the two prongs. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964680878COREHIP EXTENDEDNK1126TNK1126T2020-08-10
04046964681028COREHIP EXTENDEDNK1131TNK1131T2020-08-10
04046964681127COREHIP PRIMARYNK1201KNK1201K2020-08-10
04046964681189COREHIP PRIMARYNK1207KNK1207K2020-08-10
04046964681301COREHIP PRIMARYNK1209KNK1209K2020-08-10
04046964681349COREHIP PRIMARYNK1221KNK1221K2020-08-10
04046964681363COREHIP PRIMARYNK1223KNK1223K2020-08-10
04046964681387COREHIP PRIMARYNK1225KNK1225K2020-08-10
04046964681400COREHIP PRIMARYNK1227KNK1227K2020-08-10
04046964681424COREHIP PRIMARYNK1229KNK1229K2020-08-10
04046964681462COREHIP PRIMARYNK1241KNK1241K2020-08-10
04046964681486COREHIP PRIMARYNK1243KNK1243K2020-08-10
04046964681509COREHIP PRIMARYNK1245KNK1245K2020-08-10
04046964681523COREHIP PRIMARYNK1247KNK1247K2020-08-10
04046964681547COREHIP PRIMARYNK1249KNK1249K2020-08-10
04046963929435NOVOCARTFR719RFR719R2020-08-24
04046963933357NOVOCARTFR651RFR651R2020-08-24
04038653289509NOVOCARTFR661RFR661R2020-08-10
04046963565992NOVOCARTFR660SUFR660SU2020-04-24
04046963939588NOVOCARTFR744RFR744R2020-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810055255115Surgical DesignSurgical Design, Inc.GWX2026-05-17
09348811149084INKAThe Trustee for KAISER FAMILY TRUSTGWX2025-11-26
09348811110060INKAThe Trustee for KAISER FAMILY TRUSTGWX2025-11-21
00190776398231MillenniumAvalign Technologies, Inc.GWX2025-05-19
04049047025443GimmiGimmi GmbHGWX2025-05-06
00757770411702Bausch + LombBausch & Lomb IncorporatedGWX2024-12-23
G043630240BEARBear-Ent, LLCGWX2024-10-29
G043630250BEARBear-Ent, LLCGWX2024-10-29
G043630270BEARBear-Ent, LLCGWX2024-10-29
00887482116593Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.GWX2024-08-16
00887482116609Symmetry ForkASPEN SURGICAL PRODUCTS, INC.GWX2024-08-16
00887482116616Symmetry ForkASPEN SURGICAL PRODUCTS, INC.GWX2024-08-16
00887482116623Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.GWX2024-08-16
00887482116630Symmetry ForkASPEN SURGICAL PRODUCTS, INC.GWX2024-08-15
00887482103906Symmetry JannettaASPEN SURGICAL PRODUCTS, INC.GWX2024-08-02
00887482103913Symmetry JannettaASPEN SURGICAL PRODUCTS, INC.GWX2024-08-02
04049197305662RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
04049197305679RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
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04049197305860RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
04049197305884RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
04049197305938RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
04049197305969RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28