FDA.reportPublic FDA data

NA

Primary DI
00845384005599
Brand
NA
Company
Anspach Effort, The
Model
MUFFLER-ASSY
Catalog number
MUFFLER-ASSY
Device description
REPLACEMENT MUFFLER ASSEMBLY FOR AUTOLUBE-III
Published
2016-10-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSZINSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845384005599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845384005599008453840055998453840055990845384005599

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical power tool system, pneumaticAn assembly of devices designed to resect bones and tough tissues (e.g., cartilage, ligaments) during a surgical procedure; it is not dedicated to a specific clinical application. It includes a pneumatically-powered control unit which controls output of nitrogen (N2) or surgical-grade air via a connecting hose, motors/handpieces/power tool attachments, and a variety of tools (e.g., drill bits, saw blades, burs, milling cutters, shavers, screwdriver bits, guide wires).

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
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845384018759EG1™WIRELESS-HCWIRELESS-HC2022-07-08
00845384018766EG1™RECEIVER-HCRECEIVER-HC2022-07-08
00845384014249NAL-5B-A-G1L-5B-A-G12016-09-09
00845384012269NAHK-2100-02-FPHK-2100-02-FP2016-10-17
00845384012290NAAL-9152-00-FPAL-9152-00-FP2016-10-17
00845384002536NAHOSE-20-DISSHOSE-20-DISS2016-10-17
00845384010784NAXM-CASEXM-CASE2018-02-05
00845384010791NAXMAXXMAX2018-02-05
00845384012276NA16-3100-FP16-3100-FP2016-09-09
00845384012313NAHE-4005-10-FPHE-4005-10-FP2016-09-09
00845384012320NA45-0432-FP45-0432-FP2016-09-09
00845384016595NAE-HCE-HC2018-02-05
00845384006343NAQD11-8NDQD11-8ND2016-09-09
00845384016588NAMIA16-5DRMMIA16-5DRM2016-09-09
00845384000396NAAUTOLUBE-IIIAUTOLUBE-III2016-10-17
00845384000402NAAUTOLUBE-III-20AUTOLUBE-III-202016-10-17
00845384000457NAAUTOLUBE-III-IRRAUTOLUBE-III-IRR2016-10-17
00845384000464NAAUTOLUBE-III-MA7AUTOLUBE-III-MA72016-10-17
00845384001676NACDACDA2018-02-05
00845384001683NACDA-1RCDA-1R2016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150001989MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2026-03-09
10845854028636POWERPROConmed CorporationHSZ2023-09-01
10845854036198POWERPROConmed CorporationHSZ2023-09-01
10845854036204POWERPROConmed CorporationHSZ2023-09-01
30845854083950CONMEDConmed CorporationHSZ2022-06-06
10845854028384POWERPROConmed CorporationHSZ2021-04-19
10886982186041NASynthes GmbHHSZ2019-12-27
10886982186126NASynthes GmbHHSZ2019-12-27
10886982186317NASynthes GmbHHSZ2019-12-27
10886982186355NASynthes GmbHHSZ2019-12-27
10886982186430NASynthes GmbHHSZ2019-12-27
10886982186454NASynthes GmbHHSZ2019-12-27
10886982186478NASynthes GmbHHSZ2019-12-27
10886982186492NASynthes GmbHHSZ2019-12-27
10886982186515NASynthes GmbHHSZ2019-12-27
10886982186553NASynthes GmbHHSZ2019-12-27
10886982186645NASynthes GmbHHSZ2019-12-27
10886982186706NASynthes GmbHHSZ2019-12-27
10886982186775NASynthes GmbHHSZ2019-12-27
10886982186850NASynthes GmbHHSZ2019-12-27
10886982186874NASynthes GmbHHSZ2019-12-27
10886982185914NASynthes GmbHHSZ2019-12-26
10886982185976NASynthes GmbHHSZ2019-12-26
10886982186034NASynthes GmbHHSZ2019-12-26
10886982186119NASynthes GmbHHSZ2019-12-26
10886982186201NASynthes GmbHHSZ2019-12-26
10886982186218NASynthes GmbHHSZ2019-12-26
10886982186249NASynthes GmbHHSZ2019-12-26
10886982186270NASynthes GmbHHSZ2019-12-26
10886982186294NASynthes GmbHHSZ2019-12-26