FDA.reportPublic FDA data

NA

Primary DI
00845384005636
Brand
NA
Company
Anspach Effort, The
Model
OIL-II
Catalog number
OIL-II
Device description
Instrument Oil and One Replacement Filter for AUTOLUBE-II or AUTOLUBE- III
Published
2016-10-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845384005636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845384005636008453840056368453840056360845384005636

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument maintenance lubricantA non-sterile solution intended to be applied to a surgical instrument prior to sterilization for purposes of lubrication/maintenance (e.g., to prevent moving or mating parts from sticking together during use, inhibit corrosion, and to improve longevity of the instrument); it is not dedicated to a particular type of surgical instrument. It may be a water-soluble solution, commonly known as instrument milk because of its white colour when mixed with water, in which the instrument is immersed, or it may be a spray that is sprayed onto the instrument. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500RA-DPYNA-anspachpowe@its.jnj.com

Regulatory Flags#

DUNS number
079116867
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845384018759EG1™WIRELESS-HCWIRELESS-HC2022-07-08
00845384018766EG1™RECEIVER-HCRECEIVER-HC2022-07-08
00845384016526EG1™ High Speed SystemXL-HD-G1XL-HD-G12021-05-05
00845384018520KINCISE™1000-00-1011000-00-1012020-04-28
00845384018537KINCISE™1002-00-1021002-00-1022020-04-28
00845384018544KINCISE™1003-00-1011003-00-1012020-04-28
00845384018551KINCISE™1010-01-1011010-01-1012020-04-28
00845384018568KINCISE™1010-01-1021010-01-1022020-04-28
00845384018575KINCISE™1011-01-1011011-01-1012020-04-28
00845384018582KINCISE™1012-01-1011012-01-1012020-04-28
00845384018612KINCISE™1013-00-1011013-00-1012020-04-28
00845384018629KINCISE™1013-00-9011013-00-9012020-04-28
00845384017790Anspach HelixS-2SB-HX-G1S-2SB-HX-G12019-12-11
00845384017806Anspach HelixS-2B-HX-G1S-2B-HX-G12019-12-11
00845384017813Anspach HelixS-25SB-HX-G1S-25SB-HX-G12019-12-11
00845384017820Anspach Helix™S-25B-HX-G1S-25B-HX-G12019-12-11
00845384017837Anspach Helix™S-3SB-HX-G1S-3SB-HX-G12019-12-11
00845384017844Anspach Helix™S-3B-HX-G1S-3B-HX-G12019-12-11
00845384017851Anspach Helix™S-35SB-HX-G1S-35SB-HX-G12019-12-11
00845384017868Anspach Helix™S-35B-HX-G1S-35B-HX-G12019-12-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810111227148K-WireTreace Medical Concepts, Inc.HWE2026-03-23
10885862661555N/AExactech, Inc.HWE2026-03-19
00888867529762Arthrex®ARTHREX, INC.HWE2026-03-16
00888867529779Arthrex®ARTHREX, INC.HWE2026-03-16
00888867529809Arthrex®ARTHREX, INC.HWE2026-03-16
00888867529830Arthrex®ARTHREX, INC.HWE2026-03-16
00888867529847Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531628Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531635Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531680Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531727Arthrex®ARTHREX, INC.HWE2026-03-16
09421038412145Cup reamer handle, offset, Z/H, lockingENZTEC LIMITEDHWE2026-03-09
09421038412152Offset coupling, Z/HENZTEC LIMITEDHWE2026-03-09
09421038412169Offset drive train, lockingENZTEC LIMITEDHWE2026-03-09
09421038412176Short Offset Cover – UnitedENZTEC LIMITEDHWE2026-03-09
09421038412183Handle – UnitedENZTEC LIMITEDHWE2026-03-09
09421038412299Cup reamer handle, offset, AO, lockingENZTEC LIMITEDHWE2026-03-09
09421038412305Offset coupling, AOENZTEC LIMITEDHWE2026-03-09
09421038412312Cup reamer handle, offset, AO, openENZTEC LIMITEDHWE2026-03-09
09421038412329Offset drive train, openENZTEC LIMITEDHWE2026-03-09
09421038412671Cup reamer handle, offset, Z/H, openENZTEC LIMITEDHWE2026-03-09
00810111225601ReamerTreace Medical Concepts, Inc.HWE2026-03-02
00810111225618ReamerTreace Medical Concepts, Inc.HWE2026-03-02
00810111225625ReamerTreace Medical Concepts, Inc.HWE2026-03-02
09421038411865Enztec Modular OCI XENZTEC LIMITEDHWE2026-02-27
09421038412138Enztec Modular OCI XRENZTEC LIMITEDHWE2026-02-27
00888867536746Arthrex®ARTHREX, INC.HWE2026-02-25
00888867536760Arthrex®ARTHREX, INC.HWE2026-02-25
00888867536777Arthrex®ARTHREX, INC.HWE2026-02-25
09421038412725Enztec Reamer 36mm - BridgebackENZTEC LIMITEDHWE2026-02-23