FDA.report

NA

Primary DI
00845384017486
Brand
NA
Company
Anspach Effort, The
Model
G1-BSKT-SLV
Catalog number
G1-BSKT-SLV
Device description
G1 Cleaning and Sterilization Basket - Connector Sleeve
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

Related Records

Contact Domains

Product Codes

CodeName
LRPTRAY, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00845384017486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845384017486008453840174868453840174860845384017486

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

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

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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
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