FDA.reportPublic FDA data

NA

Primary DI
00845384001812
Brand
NA
Company
Anspach Effort, The
Model
CSRSC
Catalog number
CSRSC
Device description
Shaft Storage Cover for XMax, microMax, and eMax System Perforator Drivers.
Published
2018-02-05
Public version status
Update
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
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
00845384001812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845384001812008453840018128453840018120845384001812

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
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
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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