FDA.reportPublic FDA data

AESCULAP

Primary DI
04046955138920
Brand
AESCULAP
Company
AESCULAP IMPLANT SYSTEMS, LLC
Model
ME039R
Catalog number
ME039R
Device description
ANGLED DISTRACTOR
Published
2022-01-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046955138920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955138920040469551389204046955138920

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)229-3002setworld_orders@aesculap.com
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
622600992
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964860799ARCADIUS® XP LME177TME177T2017-03-31
04046964861000ARCADIUS® XP LME178TME178T2017-03-31
04046964942389ARCADIUS® XP LME186TME186T2016-11-13
04046964942396ARCADIUS® XP LME187TME187T2016-11-13
04046955214631ARCADIUS XP CME514ME5142024-05-13
04046955214648ARCADIUS XP CME516ME5162024-05-13
04046955214693ARCADIUS XP CME522ME5222024-05-13
04046955214709ARCADIUS XP CME524ME5242024-05-13
04046955847174activL®ME276ME2762024-04-13
04046955847990activL®ME277ME2772024-04-13
04046955848003activL®ME278ME2782024-04-13
04046955849413activL®ME279ME2792024-04-13
04046955849420activL®ME280ME2802024-04-13
04046955849437activL®ME281ME2812024-04-13
04046955849444activL®ME282ME2822024-04-13
04046955849451activL®ME405ME4052024-04-13
04046964106866AESCULAPME042ME0422024-03-01
04046964106873AESCULAPME043ME0432024-03-01
04046964106880AESCULAPME044ME0442024-03-01
04046964106897AESCULAPME045ME0452024-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506090998ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091001ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091018ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091025ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091049ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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