FDA.reportPublic FDA data

NA

Primary DI
00845384010784
Brand
NA
Company
Anspach Effort, The
Model
XM-CASE
Catalog number
XM-CASE
Device description
XMax Sterilization Case and Tray
Published
2018-02-05
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
LRPTRAY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845384010784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845384010784008453840107848453840107840845384010784

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/implant rackA device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
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
00845384005599NAMUFFLER-ASSYMUFFLER-ASSY2016-10-17
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
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10198956546431CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
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10198956572713CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956573963CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956575622CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956576575CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956577404CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956578166CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956578364CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956578715CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
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10198956583573CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
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10198956520790CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
10198956521001CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
10198956568228CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
10198956569348CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
10198956569843CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26